CLINICAL TRIALS

Current Clinical Trials
Completed Clinical Trials

Current Clinical Research Protocols
Fayaz Shawl, Md

1. The Medicines Company. APPROVE: Angiomax Peripheral Procedure Registry of Vascular Events): A study to assess the safety of replacing heparin with Angiomax® (bilvalirudin) in patients undergoing percutaneous peripheral (non-cardiac) interventional procedures. Protocol No. TMC-BIV-03-01, US IND# 35756

2. Guidant, UMDNJ-New Jersey Medical School, NINDS/NIH. Carotid Revascularization Endarterectomy vs. Stent Trial (CREST), Protocol # P99-705, IDE# G 000080

3. Boston Scientific Corporation. TAXUS V: A Randomized, Double-blind Trial to Assess TAXUS™ Paclitaxel-Eluting Coronary Stents, Slow-Release Formulation, in the Treatment of High Risk De Novo Coronary Lesions; Version 01; December 6, 2002

4. Cordis Corporation/Johnson & Johnson Company. GUARD: Saphenous Vein Graft Intervention Using AngioGuard™/AngioGuard XP™ and PercuSurge® GuardWire® for Reduction of Distal Embolization, Protocol #P99-6001

5. Boston Scientific Corporation. TAXUS V ISR: A Prospective, Randomized Trial Evaluating the Slow-Release Formulation TAXUS™ Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

6. Cordis Corporation/Johnson & Johnson Company. E-CYPHER™ Post-Market Surveillance, Protocol #P03-6321

7. Cordis Corporation/Johnson & Johnson Company. SIRIUS-2.25mm: A Multicenter, Non-Randomized Study of the 2.25mm SIROLIMUS-Eluting BX Velocity™ Balloon-Expandable Stent in the Treatment of Patients with De Novo Native Coronary Artery Lesions, Protocol #P03-6320

8. Velocimed, Inc. The PROXIMAL TRIAL: Proximal Protection during Saphenous Vein Graft Intervention using the Proxis™ Embolic Protection System: A Randomized, Prospective, Multicenter, Clinical Trial

9. ev3, Inc., An Endovascular Company. SPIDER: SVG Protection In a Distal Embolic Protection Randomized Trial, IDE #020248

10. Sanofi-Synthelabo Inc. CAMPER: Clopidogrel and Aspirin in the Management of Peripheral Endovascular Revascularization. Effect of Clopidogrel vs. Placebo, on a background of Standard Care Including Aspirin, in Maintaining the Patency of Lower Limb Arteries After Angioplasty; IND #34,663

11. The Medicines Company. The ACUITY Trial: A randomized comparison of Angiomax® (bivalirudin) versus Lovenox ®/Clexane® (enoxaparin) in patients undergoing early invasive management for acute coronary syndromes without ST-segment elevation, Protocol #TMC-BIV-02-08: US IND #35,756.

12. Pfizer Inc. Phase 3, Multi-Center Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared with Atorvastatin Alone, in Subjects with Angiographically Documented Coronary Heart Disease, Protocol #A5091005: US IND #66,458.

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Recently Completed Clinical Research Protocols
Fayaz Shawl, Md

1. Cordis, Johnson & Johnson. A Multi-center Clinical Evaluation of the Cordis Nitinol Stent Delivery System. (Carotid Feasibility, US) Protocol # P98-3601

2. Cordis/Johnson & Johnson Company. Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE), Protocol # 98-5201

3. Perclose, An Abbott Laboratories Company. A Registry Study to Evaluate the NeuroShield™ Bare Wire Cerebral Protection System and the X-act™ Stent in Patients at High Risk for Carotid Endarterectomy (SECuRITY), IDE # G010262 EndiCOR Medical, Inc. X-SIZER for Treatment of Thrombus and Atherosclerosis in Coronary Interventions Trial - Randomized and AMI Registry (X-TRACT), IDE# G980258

4. Boston Scientific Corporation. TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Elubing Stent

5. Boston Scientific Corporation. SYMBIOT™ III: A Prospective Randomized Trial Evaluating the Symbiot™ III Covered Stent System in Saphenous Vein Grafts, IDE# G000169

6. CORDIS, Johnson & Johnson Company. CSSA (Cartoid Stent) Registry IDE# 960158

7. Boston Scientific Corporation. Integra Cartoid Feasibility Protocol. IDE# G970063

8. CORDIS, Johnson & Johnson Company. A Multi-Center Clinical Evaluation of the Cartis Nitinol Stent Delivery System. Protocol # P98-3601

9. Eclispe Surgical Technologies, Inc. A Randomized Study of the Safety and Effectiveness of Percantaneous Transluminal Myocardial Revascularization (PTMR) as an Adjunct to Percuntaneous Coronary Intervention - Phase I and Training Cases. IDE# G970182

10. Eclispe Surgical Technologies, Inc. A Randomized Study of the Safety and Effectiveness of Percantaneous Transluminal Myocardial Revascularization (PTMR)- Phase II - A&B IDE# G970182

11. Guidant. ACS Multi-link and ACS Multi-link Duet Coronary Stent System with or without Adjuctive Directional Coronary Atherectomny (DCA). IDE# G980052

12. Proctor & Gamble Pharmaceuticals / Alexion Pharmaceuticals, Inc. Complement nd Reduction of Infarct size after Angioplasty or Lystics, Protocol 1999052 (COMPLY) AND Protocol 1999053

13. Cordis/Johnson & Johnson Company. Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE), Protocol # 98-5201

14. Perclose, An Abbott Laboratories Company. A Registry Study to Evaluate the Neuroshield™ Bare Wire Cerebral Protection System and the X-act™ Stent in Patients at High Risk for Cartoid Endarterectomy (SECuRITY), IDE# G010262

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