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DANIEL E. SOFFER, MD, FACC, FSCAI


Certification:

United States Medical Licensing Examination (USMLE)
                     Step I and II - Passed, 1st Attempt - 1993, Step III -
         st
Passed, 1 Attempt - 1995
         1994        Educational Commission for Foreign Medical
Graduates (ECFMG # 0-476-774-5)
         1997        Board Certified and Diplomate, American Board of
Internal Medicine (ABIM)
         2000        Board Certified and Diplomate, ABIM,
Cardiovascular Disease # 179302
         2002        Board Certified and Diplomate, ABIM, Interventional
Cardiology
         2011        Board Certified, Endovascular Medicine, American
Board of Vascular Medicine
        Present      Basic and Advanced Cardiac Life Support (BCLS
and ACLS)

Licensing:           DEA # BS6887294
                     Michigan License # 4301076758
                     New York License # 224099-1
                     North Carolina License # 2002-01311

Current Position:     Co- Director, Carotid Endovascular Services
                      Intervntional Cardiology
                      Zena and Michael A Wiener Cardiovascular Institute
                      Marie Josee and Henry R. Kravis Center for Cardiovascular Health
                      Mount Sinai Medical Center
                      One Gustave L. Levy Place, Box 1030
                      New York, NY 10029-6574

                      Director, Vascular Medicine Laboratory
                      The Mount Sinai Heart and Vascular Center
                      485 Madison Avenue, New York, NY 10022

Previous Position:    Associate Director, Fellowship Program
                      Interventional Cardiology, Structural Heart, Endovascular & Carotid Interventions
                      Department of Interventional Cardiology
                      Lenox Hill Heart and Vascular Institute
                      New York, NY 10075

                      Carolina Heart PA
                      Interventional Cardiology, Structural Heart, Endovascular & Carotid Interventions
                      Pitt County Memorial Hospital
                      Greenville, North Carolina
Current Clinical    Associate Professor of Medicine
Appointment:        Department of Internal Medicine
                    Mount Sinai School of Medicine

Previous Clinical   Associate professor of medicine
Appointments:       Department of Internal Medicine
                    Brody School of Medicine
                    East Carolina University
                    Greenville, North Carolina

Postgraduate Training and Fellowships:

9/2000-8/2002       Fellowship (PGY 7-8), Interventional Cardiology, Peripheral and Carotid
                    Interventions, Structural heart, Aortic and Mitral valvuloplasty
                    William Beaumont Hospital, Royal Oak, MI

7/1997-6/2000       Fellowship (PGY 4-6), Clinical Cardiology
                    Lenox Hill Hospital, New York, NY

7/1995-6/1997       Residency (PGY 2-3), Internal Medicine
                    Lenox Hill Hospital, New York, NY

7/1994-6/1995       Internship (PGY 1), Internal Medicine
                    Lenox Hill Hospital, New York, NY

Medical Education and Academic Honors:

10/1985-4/1993      M.D., Ben Gurion University of the Negev, Beer Sheva, Israel

Summer 1989         Visiting Honorary Student, Cardiothoracic Surgery
                    Üelleval Hospital, Oslo, Norway

 Summer 1990        Selected Honorary Student, Cardiology and Emergency Medicine
                    Albert Einstein College of Medicine, Bronx, New York

 1990 and 1991      Two - Time Recipient, Swiss Foundation Scholarship
                    (Awarded to the top 8 out of 200 students for clinical excellence in medicine)

  1991-1992         Thesis: “Changes in Pressure Exerted on the Foot During Pregnancy”
                    Ben Gurion University of the Negev, Beer Sheva, Israel

 4/1992-3/1993      Rotating Internship, Chaim Sheba Medical Center, Tel Hashomer, Israel

Military Service:   First Lieutenant, Medical Corps
                    Israel Defense Forces
   1981-1982        Combat Medic and Medic Course Instructor
   1983-1984        Medic Course Commander
   1984-1985        Chief Instructing Officer, School of Military Medicine
High School Education:

    1977-1981     Makif Yahud, Yahud, Israel
                  Major Subjects: Biology and Chemistry
                  Graduated with High Honors
Memberships/Fellowships:

 1985-Present          CMAS world underwater federation
 1997-Present          American College of Cardiology – Fellow
 2003-present          The Society for Cardiac Angiography & Interventions- Fellow

Primary Investigator / Sub-investigator
Primary Investigator, Evaluation of the Cascade Abrazo Analyzer and DTM (Direct Thrombin Monitor) Test
Card Bivalirudin (“Abrazo DTM”), Sponsored by Helena Labs.

Primary Investigator, ORBIT II Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°®
Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions, Sponsored by
Cardiovascular Systems Inc. (CSI).

SUPERB Comparison of the Supera PERipheral System to a Performance Goal derived from Balloon
Angioplasty Clinical Trials in the Superficial Femoral Artery, Sponsored by IDEV Technologies, Inc.


Choice Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The CollectIon Of Clinical
Evidence

Sapphire WW - STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR
ENDARTERECTOMY Protocol Number P06-3603

Protect Protected Carotid Artery Stenting in Subjects at High Risk for CEA

Proguard Trial- Protection During Carotid Stenting in High Risk Patients with the TriActive ProGUARD System

VIVA Trial - VIVEXX™ Carotid Revascularization for High Surgical Risk Patients with Extracranial Carotid Artery
Stenosis using the Bard® VIVEXX™ Carotid Stent and Emboshield® Bare Wire™ Rapid Exchange Embolic
Protection System

MAVERIC III – Medtronic Evaluation of the Medtronic AVE Self-Expanding Carotid Stent System with Distal
Protection in the Treatment of Carotid Stenosis

Tracer A Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy
of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor
Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA·CER)

Zomaxx II ZOMAXX II- Trial-A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the
Zomaxx™ Drug Eluting Coronary Stent System as Compared to the Taxus™ Express2™ Paclitaxel-Eluting Stent in
de novo Coronary Artery Lesions

Gravitas Gauging Responsiveness with A VerifyNow assay- Impact on Thrombosis And Safety (GRAVITAS)
Xience   XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study

Reform REFORM- Evaluation of Effectiveness and Safety of the Formula™ Balloon-Expandable Stent for Renal
Artery Stenosis

Endeavor SVS A Clinical Evaluation of the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the
Treatment of Single De novo Lesions in Small Diameter Native Coronary Arteries (Endeavor SVS)

Resolute A Clinical Evaluation of the Medtronic Endeavor® Resolute Zotarolimus-Eluting Coronary Stent System in
the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2
mm - The Medtronic RESOLUTE US Clinical Trial

Realism EVEREST II Continued Access Registry

Intense Iliac artery treatmeNT with thE iNvatec Scuba cobalt chromium stEnt (INTENSE) Study

Liberte TAXUS Libertē Post-Approval Study

Superb Comparison of the SUpera® PERipheral System to a Performance Goal derived from Balloon Angioplasty
Clinical Trials in the Superficial Femoral Artery (The SUPERB Study)

Dapt A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus
30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with
either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.

FREEDOM Trial – Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of
Multivessel Disease

DELTA MI Trial – Direct Inhibition of Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial
Infarction

PREMIUM Trial- Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects
with Migrane and Patent Foramen Ovale Using the AMPLATZER PFO Occluder Compared to Medical Management

AMEthyst Trial – A Prospective, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of the
Interceptor Embolic Protection Device During Transluminal Percutaneous Coronary Interventions on Saphenous
Grafts

EVENT Registry- A Multicenter Registry for the Evaluation of Drug Eluting Stents and Ischemic Events

DYNAMIC Registry- Dynamic Evaluation of Percutaneous Intervention

ASPIRE Trial- Angioplasty in SVG’s with Post Intervention Removal of Embolic Debris

ZILVER Trial – Evaluation of the Zilver® PTX™ Vascular Stent in the Above-the-Knee Femoropopliteal
   Artery Clinical Study Protocol: Phase I

SIRIUS Trial - A Multicenter, Randomized, Double-Blind study of the SIROLIMUS Coated Bx VELOCITY Stent
in the Treatment of Patients with de-novo Coronary Artery Lesions

CARDIOSEAL Septal Occlusion System Registry
TRAP Vascular Filtration System Trial – Randomized Study of TRAP Filter Device in Saphenous Vein Graft
PTCA/Stenting

A Phase II Randomized Multicenter Clinical Study To Evaluate the Safety and Efficacy of the TandemHeart
pVAD System vs. Conventional Therapy for Treatment of Cardiogenic Shock

TherOx AO System AMIHOT Trial – Acute Myocardial Infarction with Hyperoxemic Therapy

FIRE Trial- Distal Protection with BSC/EPI Filterwire vs. PercuSurge Guardwire During SVG Stenting

COOL-MI Trial - Hypothermia as an Adjunctive Therapy to PTCA in Patients with Acute MI

BARRICADE Trial – PCI with the JOMED PTFE Covered Stent in Degenerated Saphenous Vein Grafts


Publications & Presentations:

             Carotid Artery Stenting in Elderly Patients: Importance of Case Selection
             Cathet Cardiovasc Intervent 2008;72:318-324
             Paul T.L. Chiam, Gary S. Roubin,Sriram S. Iyer, Richard M. Green, Daniel E. Soffer,
             Christina Brennan, Jiri J. Vitek

              Prospective Evaluation of Aggressive Medical Therapy for Atherosclerotic renal artery
              stenosis, with Renal Artery Stenting Reserved for Previously Injured Heart, Brain, or
              Kidney
              Hanzel G, Balon H, Wong D, Soffer D, Lee DT, Safian RD
              Am J Cardiol. 2005 Nov 1;96(9):1322-7 Epub 2005 Sep 1

              Impact of Angina Class on Inhibition of Platelet Aggregation Following Clopidogrel
              Loading in Patients Undergoing Coronary Intervention: Do We Need More Aggressive
              Dosing Regimens in Unstable Angina?
              Cathet Cardiovasc Intervent 2003;59:21-25
              Daniel Soffer1, Issam Moussa2, Kishore J. Harjai1, Judith Boura1, Simon R. Dixon1, Cindy L.
              Grines1, William W. O’Neill1 , Gary S. Roubin2, Jeffrey W. Moses2,
              William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New
              York, NY, USA

              Sub-Optimal Inhibition of Platelet Aggregation Following Tirofiban Bolus in Patients
              Undergoing Coronary Intervention for Unstable Angina Pectoris
              Am J Cardiol 2003;91:872-875
              Daniel Soffer1, Issam Moussa2, Murat Karatepe2, Kishore J. Harjai1, Judith Boura1, Simon R.
              Dixon1, Cindy L. Grines1, William W. O’Neill 1, Gary S. Roubin2
              Jeffrey W. Moses2
              William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New
              York, NY, USA

              Images in cardiology: postpartum intramural hematoma-evaluation by computed
              tomographic angiography.
              J Clin Hypertens (Greenwich). 2009 Nov;11(11):656.
              Haden G, Polenta S, Jelnin V, Soffer D, Hecht H.
Platelet Aggregtion Inhibition in Patients Receiving Statins Either Fully or Partially
 Metabolized by CYP3A4
Polena S, Gupta MP, Shaikh H, Zazzali K, Coplan N, Gintnutas J, Labana SS, Soffer D
Proc West Pharmacol Soc. 2008;51:60-2

Renal Stenting Preserves Single Kidney GFR and Renal Mass Compared to Medical
Therapy in Patients with Renal Artery Stenosis: 17 Months Follow-up
Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2002
Daniel Soffer, Daniel T. Lee, Helena Balon, Staci Barnhart, Judith A. Boura, Simon R. Dixon,
William W. O’Neill, Robert D. Safian
William Beaumont Hospital, Royal Oak, MI

Inter-assay Variability in the Degree of Platelet Inhibition Following GPIIb/IIIa Receptor
Blockade in Patients Undergoing Coronary Intervention: A Comparison of Three
Different Point-of-Care Assays.
Presented at the 51th annual session of the American College of Cardiology, 2002
Daniel Soffer1, William W. O’Neill1, Kishore J. Harjai1, Judith Boura1, Robert D. Safian1,
Cindy Grines1, Issam Moussa2, Gary S. Roubin2, Jeffrey W. Moses2.
William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New
York, NY, USA

The Impact of Clinical Presentation on the Degree of Platelet Inhibition at Baseline and
following Glycoprotein IIb/IIIa Receptor Blockade in Patients Undergoing Percutaneous
Coronary Intervention (abstract)
Presented at the 49th annual session of the American College of Cardiology, 2000
J Am Coll Cardiol 2000;35, Supp 43A
                       Soffer D, Taviloglu G, New G, Kreps E, Collins M, Iyer S, Roubin G,
Moses J, Coplan N, Moussa I
Lenox Hill Heart and Vascular Institute, New York, NY, USA

What is the Appropriate Loading Dose of Clopidogrel Prior to Stent Implantation?
Insights from a Platelet Inhibition Study (abstract)
Presented at the 49th annual session of the American College of Cardiology, 2000
J Am Coll Cardiol 2000;35, Supp 307A
Soffer D, Taviloglu G, New G, Kreps E, Collins M, Iyer S, Roubin G, Colombo A, Moses J,
Coplan N, Moussa I
Lenox Hill Heart and Vascular Institute, New York, NY, USA

Is it Safe to Perform Coronary Intervention in Patients with Occult Blood in Stool and
Stable Hemoglobin? (abstract)
Presented at the 49th annual session of the American College of Cardiology, 2000
J Am Coll Cardiol 2000;35, Supp 32A
Taviloglu G, Soffer D, New G, Baiocco P, Aboufares A, Glasser L, Zlatanic J, Coplan N,
Moses J, Moussa I
Lenox Hill Heart and Vascular Institute, New York, NY, USA
Does Clinical presentation Impact Platelet Inhibition at Baseline and Following
              Glycoprotein IIb/IIIa Receptor Blockade in Patents Undergoing Percutaneous Coronary
              Intervention? (abstract)
              Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2000
              Karatepe M, Soffer D, Mani A, Taviloglu G, Kreps E, Collins M, Iyer S, Coplan N, Roubin G
               Lenox Hill Heart and Vascular Institute, New York, NY, USA

              Clopidogrel Loading Prior to Coronary Stent Implantation, What is the Appropriate
              Dose? (abstract)
              Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2000
              Karatepe M, Mani A, Soffer D, Taviloglu G, Kreps E, Collins M, Iyer S, Glasser L, Coplan N,
              Roubin G
              Lenox Hill Heart and Vascular Institute, New York, NY, USA

              The Relationship Between Creatine Kinase Elevation after Single Vessel Intervention and
              Long-Term Outcome, Causation or Association? (abstract)
              Presented at the 73rd scientific sessions of the American Heart Association, 2000
                                              Aboufares A, Lasic Z, Khanna A, Minutillo J, Soffer D,
              Taviloglu G, Coplan N, Moses J, Moussa I
              Lenox Hill Heart and Vascular Institute, New York, NY, USA

References:    Available upon request

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  • 1. DANIEL E. SOFFER, MD, FACC, FSCAI Certification: United States Medical Licensing Examination (USMLE) Step I and II - Passed, 1st Attempt - 1993, Step III - st Passed, 1 Attempt - 1995 1994 Educational Commission for Foreign Medical Graduates (ECFMG # 0-476-774-5) 1997 Board Certified and Diplomate, American Board of Internal Medicine (ABIM) 2000 Board Certified and Diplomate, ABIM, Cardiovascular Disease # 179302 2002 Board Certified and Diplomate, ABIM, Interventional Cardiology 2011 Board Certified, Endovascular Medicine, American Board of Vascular Medicine Present Basic and Advanced Cardiac Life Support (BCLS and ACLS) Licensing: DEA # BS6887294 Michigan License # 4301076758 New York License # 224099-1 North Carolina License # 2002-01311 Current Position: Co- Director, Carotid Endovascular Services Intervntional Cardiology Zena and Michael A Wiener Cardiovascular Institute Marie Josee and Henry R. Kravis Center for Cardiovascular Health Mount Sinai Medical Center One Gustave L. Levy Place, Box 1030 New York, NY 10029-6574 Director, Vascular Medicine Laboratory The Mount Sinai Heart and Vascular Center 485 Madison Avenue, New York, NY 10022 Previous Position: Associate Director, Fellowship Program Interventional Cardiology, Structural Heart, Endovascular & Carotid Interventions Department of Interventional Cardiology Lenox Hill Heart and Vascular Institute New York, NY 10075 Carolina Heart PA Interventional Cardiology, Structural Heart, Endovascular & Carotid Interventions Pitt County Memorial Hospital Greenville, North Carolina
  • 2. Current Clinical Associate Professor of Medicine Appointment: Department of Internal Medicine Mount Sinai School of Medicine Previous Clinical Associate professor of medicine Appointments: Department of Internal Medicine Brody School of Medicine East Carolina University Greenville, North Carolina Postgraduate Training and Fellowships: 9/2000-8/2002 Fellowship (PGY 7-8), Interventional Cardiology, Peripheral and Carotid Interventions, Structural heart, Aortic and Mitral valvuloplasty William Beaumont Hospital, Royal Oak, MI 7/1997-6/2000 Fellowship (PGY 4-6), Clinical Cardiology Lenox Hill Hospital, New York, NY 7/1995-6/1997 Residency (PGY 2-3), Internal Medicine Lenox Hill Hospital, New York, NY 7/1994-6/1995 Internship (PGY 1), Internal Medicine Lenox Hill Hospital, New York, NY Medical Education and Academic Honors: 10/1985-4/1993 M.D., Ben Gurion University of the Negev, Beer Sheva, Israel Summer 1989 Visiting Honorary Student, Cardiothoracic Surgery Üelleval Hospital, Oslo, Norway Summer 1990 Selected Honorary Student, Cardiology and Emergency Medicine Albert Einstein College of Medicine, Bronx, New York 1990 and 1991 Two - Time Recipient, Swiss Foundation Scholarship (Awarded to the top 8 out of 200 students for clinical excellence in medicine) 1991-1992 Thesis: “Changes in Pressure Exerted on the Foot During Pregnancy” Ben Gurion University of the Negev, Beer Sheva, Israel 4/1992-3/1993 Rotating Internship, Chaim Sheba Medical Center, Tel Hashomer, Israel Military Service: First Lieutenant, Medical Corps Israel Defense Forces 1981-1982 Combat Medic and Medic Course Instructor 1983-1984 Medic Course Commander 1984-1985 Chief Instructing Officer, School of Military Medicine
  • 3. High School Education: 1977-1981 Makif Yahud, Yahud, Israel Major Subjects: Biology and Chemistry Graduated with High Honors Memberships/Fellowships: 1985-Present CMAS world underwater federation 1997-Present American College of Cardiology – Fellow 2003-present The Society for Cardiac Angiography & Interventions- Fellow Primary Investigator / Sub-investigator Primary Investigator, Evaluation of the Cascade Abrazo Analyzer and DTM (Direct Thrombin Monitor) Test Card Bivalirudin (“Abrazo DTM”), Sponsored by Helena Labs. Primary Investigator, ORBIT II Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions, Sponsored by Cardiovascular Systems Inc. (CSI). SUPERB Comparison of the Supera PERipheral System to a Performance Goal derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery, Sponsored by IDEV Technologies, Inc. Choice Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The CollectIon Of Clinical Evidence Sapphire WW - STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMY Protocol Number P06-3603 Protect Protected Carotid Artery Stenting in Subjects at High Risk for CEA Proguard Trial- Protection During Carotid Stenting in High Risk Patients with the TriActive ProGUARD System VIVA Trial - VIVEXX™ Carotid Revascularization for High Surgical Risk Patients with Extracranial Carotid Artery Stenosis using the Bard® VIVEXX™ Carotid Stent and Emboshield® Bare Wire™ Rapid Exchange Embolic Protection System MAVERIC III – Medtronic Evaluation of the Medtronic AVE Self-Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis Tracer A Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA·CER) Zomaxx II ZOMAXX II- Trial-A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the Zomaxx™ Drug Eluting Coronary Stent System as Compared to the Taxus™ Express2™ Paclitaxel-Eluting Stent in de novo Coronary Artery Lesions Gravitas Gauging Responsiveness with A VerifyNow assay- Impact on Thrombosis And Safety (GRAVITAS)
  • 4. Xience XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study Reform REFORM- Evaluation of Effectiveness and Safety of the Formula™ Balloon-Expandable Stent for Renal Artery Stenosis Endeavor SVS A Clinical Evaluation of the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment of Single De novo Lesions in Small Diameter Native Coronary Arteries (Endeavor SVS) Resolute A Clinical Evaluation of the Medtronic Endeavor® Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2 mm - The Medtronic RESOLUTE US Clinical Trial Realism EVEREST II Continued Access Registry Intense Iliac artery treatmeNT with thE iNvatec Scuba cobalt chromium stEnt (INTENSE) Study Liberte TAXUS Libertē Post-Approval Study Superb Comparison of the SUpera® PERipheral System to a Performance Goal derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery (The SUPERB Study) Dapt A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions. FREEDOM Trial – Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease DELTA MI Trial – Direct Inhibition of Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction PREMIUM Trial- Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migrane and Patent Foramen Ovale Using the AMPLATZER PFO Occluder Compared to Medical Management AMEthyst Trial – A Prospective, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of the Interceptor Embolic Protection Device During Transluminal Percutaneous Coronary Interventions on Saphenous Grafts EVENT Registry- A Multicenter Registry for the Evaluation of Drug Eluting Stents and Ischemic Events DYNAMIC Registry- Dynamic Evaluation of Percutaneous Intervention ASPIRE Trial- Angioplasty in SVG’s with Post Intervention Removal of Embolic Debris ZILVER Trial – Evaluation of the Zilver® PTX™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery Clinical Study Protocol: Phase I SIRIUS Trial - A Multicenter, Randomized, Double-Blind study of the SIROLIMUS Coated Bx VELOCITY Stent in the Treatment of Patients with de-novo Coronary Artery Lesions CARDIOSEAL Septal Occlusion System Registry
  • 5. TRAP Vascular Filtration System Trial – Randomized Study of TRAP Filter Device in Saphenous Vein Graft PTCA/Stenting A Phase II Randomized Multicenter Clinical Study To Evaluate the Safety and Efficacy of the TandemHeart pVAD System vs. Conventional Therapy for Treatment of Cardiogenic Shock TherOx AO System AMIHOT Trial – Acute Myocardial Infarction with Hyperoxemic Therapy FIRE Trial- Distal Protection with BSC/EPI Filterwire vs. PercuSurge Guardwire During SVG Stenting COOL-MI Trial - Hypothermia as an Adjunctive Therapy to PTCA in Patients with Acute MI BARRICADE Trial – PCI with the JOMED PTFE Covered Stent in Degenerated Saphenous Vein Grafts Publications & Presentations: Carotid Artery Stenting in Elderly Patients: Importance of Case Selection Cathet Cardiovasc Intervent 2008;72:318-324 Paul T.L. Chiam, Gary S. Roubin,Sriram S. Iyer, Richard M. Green, Daniel E. Soffer, Christina Brennan, Jiri J. Vitek Prospective Evaluation of Aggressive Medical Therapy for Atherosclerotic renal artery stenosis, with Renal Artery Stenting Reserved for Previously Injured Heart, Brain, or Kidney Hanzel G, Balon H, Wong D, Soffer D, Lee DT, Safian RD Am J Cardiol. 2005 Nov 1;96(9):1322-7 Epub 2005 Sep 1 Impact of Angina Class on Inhibition of Platelet Aggregation Following Clopidogrel Loading in Patients Undergoing Coronary Intervention: Do We Need More Aggressive Dosing Regimens in Unstable Angina? Cathet Cardiovasc Intervent 2003;59:21-25 Daniel Soffer1, Issam Moussa2, Kishore J. Harjai1, Judith Boura1, Simon R. Dixon1, Cindy L. Grines1, William W. O’Neill1 , Gary S. Roubin2, Jeffrey W. Moses2, William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New York, NY, USA Sub-Optimal Inhibition of Platelet Aggregation Following Tirofiban Bolus in Patients Undergoing Coronary Intervention for Unstable Angina Pectoris Am J Cardiol 2003;91:872-875 Daniel Soffer1, Issam Moussa2, Murat Karatepe2, Kishore J. Harjai1, Judith Boura1, Simon R. Dixon1, Cindy L. Grines1, William W. O’Neill 1, Gary S. Roubin2 Jeffrey W. Moses2 William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New York, NY, USA Images in cardiology: postpartum intramural hematoma-evaluation by computed tomographic angiography. J Clin Hypertens (Greenwich). 2009 Nov;11(11):656. Haden G, Polenta S, Jelnin V, Soffer D, Hecht H.
  • 6. Platelet Aggregtion Inhibition in Patients Receiving Statins Either Fully or Partially Metabolized by CYP3A4 Polena S, Gupta MP, Shaikh H, Zazzali K, Coplan N, Gintnutas J, Labana SS, Soffer D Proc West Pharmacol Soc. 2008;51:60-2 Renal Stenting Preserves Single Kidney GFR and Renal Mass Compared to Medical Therapy in Patients with Renal Artery Stenosis: 17 Months Follow-up Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2002 Daniel Soffer, Daniel T. Lee, Helena Balon, Staci Barnhart, Judith A. Boura, Simon R. Dixon, William W. O’Neill, Robert D. Safian William Beaumont Hospital, Royal Oak, MI Inter-assay Variability in the Degree of Platelet Inhibition Following GPIIb/IIIa Receptor Blockade in Patients Undergoing Coronary Intervention: A Comparison of Three Different Point-of-Care Assays. Presented at the 51th annual session of the American College of Cardiology, 2002 Daniel Soffer1, William W. O’Neill1, Kishore J. Harjai1, Judith Boura1, Robert D. Safian1, Cindy Grines1, Issam Moussa2, Gary S. Roubin2, Jeffrey W. Moses2. William Beaumont Hospital, Royal Oak, MI; Lenox Hill Heart and Vascular Institute, New York, NY, USA The Impact of Clinical Presentation on the Degree of Platelet Inhibition at Baseline and following Glycoprotein IIb/IIIa Receptor Blockade in Patients Undergoing Percutaneous Coronary Intervention (abstract) Presented at the 49th annual session of the American College of Cardiology, 2000 J Am Coll Cardiol 2000;35, Supp 43A Soffer D, Taviloglu G, New G, Kreps E, Collins M, Iyer S, Roubin G, Moses J, Coplan N, Moussa I Lenox Hill Heart and Vascular Institute, New York, NY, USA What is the Appropriate Loading Dose of Clopidogrel Prior to Stent Implantation? Insights from a Platelet Inhibition Study (abstract) Presented at the 49th annual session of the American College of Cardiology, 2000 J Am Coll Cardiol 2000;35, Supp 307A Soffer D, Taviloglu G, New G, Kreps E, Collins M, Iyer S, Roubin G, Colombo A, Moses J, Coplan N, Moussa I Lenox Hill Heart and Vascular Institute, New York, NY, USA Is it Safe to Perform Coronary Intervention in Patients with Occult Blood in Stool and Stable Hemoglobin? (abstract) Presented at the 49th annual session of the American College of Cardiology, 2000 J Am Coll Cardiol 2000;35, Supp 32A Taviloglu G, Soffer D, New G, Baiocco P, Aboufares A, Glasser L, Zlatanic J, Coplan N, Moses J, Moussa I Lenox Hill Heart and Vascular Institute, New York, NY, USA
  • 7. Does Clinical presentation Impact Platelet Inhibition at Baseline and Following Glycoprotein IIb/IIIa Receptor Blockade in Patents Undergoing Percutaneous Coronary Intervention? (abstract) Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2000 Karatepe M, Soffer D, Mani A, Taviloglu G, Kreps E, Collins M, Iyer S, Coplan N, Roubin G Lenox Hill Heart and Vascular Institute, New York, NY, USA Clopidogrel Loading Prior to Coronary Stent Implantation, What is the Appropriate Dose? (abstract) Presented at the Transcatheter and Cardiovascular Therapeutics, Washington DC, 2000 Karatepe M, Mani A, Soffer D, Taviloglu G, Kreps E, Collins M, Iyer S, Glasser L, Coplan N, Roubin G Lenox Hill Heart and Vascular Institute, New York, NY, USA The Relationship Between Creatine Kinase Elevation after Single Vessel Intervention and Long-Term Outcome, Causation or Association? (abstract) Presented at the 73rd scientific sessions of the American Heart Association, 2000 Aboufares A, Lasic Z, Khanna A, Minutillo J, Soffer D, Taviloglu G, Coplan N, Moses J, Moussa I Lenox Hill Heart and Vascular Institute, New York, NY, USA References: Available upon request