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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