Barry S. Weinstock Research Activities

PRINCIPAL INVESTIGATOR

CREST: “Carotid Revascularization Endarterectomy versus Stent Trial (Crest)”, Sponsor: Advanced Cardiovascular Systems, Inc. Protocol#99-705, (Orlando Regional Medical Center), June 2001 – 2013

CANOPY: “Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy” Sponsor: Abbott Vascular, (Orlando Regional Medical Center), June 2012 – 2013
TRANSLATE-ACS: “Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome Registry”, Sponsor: Eli Lilly & Company, (Orlando Regional Medical Center) 2012 – 2013

Evaluation of the GORE TIGRIS® Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries. Protocol Number: PCE 09-02. Sponsor: W.L. Gore & Associates, Inc. (Orlando Regional Medical Center) Jan 2012 – 2013

A Prospective, Single-Arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Acute Pulmonary Embolism (SEATTLE-II). Sponsor: Ekos, Inc. (Orlando Regional Medical Center) 2012-2013

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 (ORBIT II) Protocol No: CP-2009-001. Sponsor: Cardiovascular Systems, Inc. (Orlando Regional Medical Center) 2010-2011

SPIRIT PRIME: A Clinical Evaluation of the XIENCE PRIME ™ and XIENCE PRIME ™ LL

Everolimus Eluting Coronary Stent System. Protocol 06-373. Sponsor: Abbott Vascular. (Orlando Regional Medical Center) 2009

A Prospective, Randomized, Open Label, Multicenter, Pilot Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients with Chronic Obstructive Pulmonary Disease. Protocol Number: US-01. Sponsor: Rox Medical. (Orlando Regional Medical Center) 2009.

INTENSE: Iliac artery treatmeNT with thE iNvatec ScubaSCUBA cobalt chromium stent. Sponsor: Invatec. Protocol Number: #P-999. (Orlando Regional Medical Center) 2009

DEFINITE Ca++: Determination of Safety and Effectiveness of the SilverHawk Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX Embolic™ Protection Device (SpiderFX) for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries. Sponsor: ev3. Protocol Number: FHT-P-07-003. (Orlando Regional Medical Center) 2009

CREATE-PAS: Carotid Revascularization with ev3 Arterial Technology Evolution – PostApproval Study. Sponsor: ev3. Protocol P-2611. (Orlando Regional Medical Center) 2007-

REFORM: Evaluation of Effectiveness and Safety of the Formula Balloon Expandable Stent for Renal Artery Stenosis. Sponsor: Cook Incorporated. Protocol 06-581. (Orlando Regional Medical Center) 2009-09.

CHAMPION: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III heart failure patients. Sponsor: CardioMems. Protocol CM-06-04 2007. (Orlando Regional Medical Center). 2008 –

PLATO: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with NonST or ST Elevation
Acute Coronary Syndromes (ACS) (PLATO – A Study of PLATelet inhibition and Patient Outcomes.) Sponsor: Astra Zeneca. Protocol: D5130C05262. 2007. (Orlando Regional Medical Center).

ATLAS: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes:

The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with or without thienopyridine therapy in Subjects with Acute Coronary Syndrome). Sponsor: Johnson & Johnson. Protocol 39039039ACS2001. 2007 (Orlando Regional Medical Center).

OASIS: Clinical Study of the Orbital Atherectomy Study for the Treatment of Peripheral Vascular Stenosis. Sponsor: Cardiovascular Systems, Inc. 2006 (Florida Hospital)

CELLO: CLiRpath® Excimer LaserSystem to Enlarge Lumen Openings. Sponsor: Spectranetics Corporation. 2006 (Florida Hospital)

TIFFANY: Targeted Infusion of Fenoldopam For Avoidance of NephropathY (FEN-002). Sponsor: Flow Medica, Inc. 2005 (Florida Hospital) BROADWING: Biological Waste MateRial and Outcomes Analysis of Lower Extremity Peripheral Disease Treated With the SIlverHawk™ Plaque ExcisioN System: A Tissue and Data ReGistry. Protocol No.: FHT-P-05-004. Sponsor: FoxHollow Technologies, Inc. 2005 (Florida Hospital)

PATRICIA: Peripheral Angiographers’ Targeted Renal Infusion for Contrast Injury Avoidance Trial: A Single-Center Randomized, Open-Label Trial of Intra-Renal Fenoldopam vs. Intravenous Sodium Bicarbonate and Oral Mucomyst in Patients at High Risk for Radiocontrast Nephropathy Undergoing Peripheral Vascular Intervention. Physician Sponsored. Supported by Flow Medica, Inc. 2005 (Florida Hospital)

TRITON: “A Comparison of CS-747 and Clopidogrel in Acute Coronary Dyndrome Subjects who are to Undergo Percutaneous Coronary Intervention/TIMI-38”, Eli Lilly and Company. Protocol H7T-MC-TAAL, August 10, 2004. (Orlando Regional Medical Center)

MOMENTUM: Multicenter trial of the Orqis Medical Cardiac Recovery System for the Enhanced Treatment of CHF Unresponsive to Medical Therapy. Sponsor: Orqis Medical. 2005 (Florida Hospital)

FINESSE: Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events. Sponsor: Centocor. 2002 (Northside Hospital)
Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events, Part 2: REPLACE-2. Sponsor: The Medicines Company. 2002 (Northside Hospital)

Biotronik Philos DR Active Capture Control Clinical Investigation. Biotronik 2002 Biotronik INOS 2+CLS Pacemaker Study. Sponsor: Biotronik, 2000-2001 (Northside Hospital)

HART II – “An Open Labeled, Randomized, Parallel, Multicenter Trial Comparing the Study and Efficacy of Subcutaneous Enoxaparin to Intravenous Unfractionated Heparin as an Adjunct to Thrombolytic Therapy in Patients Presenting with Acute Myocardial Infarction”, Sponsor: Rhone-Poulenc Rorer, Protocol #ENO-CMA-201, 1999.

RV Sheath Protocol – “A Randomized Trial of New Ventricular Pacemaker Lead Placement Technique Versus Standard Procedure”, Sponsor: Biotronik and Bay Area Heart Center, 1998.

“Document the Clinical Performance of the Polyrox Pacing Leads, # PX60-BP and PX53-BP Bipolar Ventricular Pacing Leads and PX53-JBP and PX45-JBP Bipolar Atrial Pacing Leads”,

Sponsor: Biotronik, 1997.

CENTER- “A Randomized Comparison of the ACT-One Coronary Stent versus the PalmazSchatz Stent in the Treatment of Patients with De Novo and Restenosis Native Coronary Artery Lesions”, Sponsor:

Progressive Angioplasty Systems, Inc., 1996.

“Evaluate the Safety and Efficacy of the Passive Plus DX (Models 1342T/1346T) Pacing Leads”, Sponsor: Pacesetter, 1996.

SUB-INVESTIGATOR
“A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System”, Boston Scientific, February 2013. (Orlando Regional Medical Center)

REVIVE: “A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Ixmyelocel-T in Subjects with Critical Limb
Ischemia and No Options for Revascularization”, Aastrom Biosciences, 2013. (Orlando Regional Medical Center)

TRITON: “A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention/TIMI-38”, Eli Lilly and Company. Protocol H7T-MC-TAAL, August 10, 2004. (Florida Hospital)

ZOMAXX II: “A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System as Compared to the TAXUS Express2 PaclitaxelEluting Stent in de novo Coronary Artery Lesions”, Abbott Vascular Devices, April 2005.

COSTAR II TRIAL: “Cobalt Chromium Stent with Antiproliferative for Restenosis II Trial”, Sponsor: Conor Medsystems, June 2005.

TAXUS ATLAS SMALL VESSEL: “A multi-center, single-arm study of the TAXUS LiberteSR Stent for the treatment of patients with de novo coronary artery lesions in small vessels”, Sponsor: Boston
Scientific, July 2004.

TAXUS ATLAS DIRECT STENT: “A multi-center, single-arm study of the TAXUS Liberte-SR Stent for the direct stenting treatment of patients with de novo coronary artery lesions”, Sponsor: Boston Scientific, July 2004.

TAXUS ATLAS LONG LESION: “A multi-center, single-arm study of the TAXUS Liberte-SR Stent for the treatment of patients with long de novo coronary artery lesions”, Sponsor: Boston Scientific, July 2004.

BOOMERANG Interventional Trial: Boomerang ClosureWire Vascular Closure System in Use of Femoral Artery Closure in Interventional Settings. Protocol# Dx0401, Cardiva Medical, Inc.

TAXUS ATLAS: “A multi-center, single-arm study of the TAXUS Liberte-SR Stent for the treatment of patients with de novo coronary artery lesions”, Sponsor: Boston Scientific, July 2004.
ENDEAVOR III — “A blinded randomized trial of the Medtronic Endeavor Drug (ABT-578) Eluting Stent System versus the Cypher Sirolimus-Eluting Stent System in de novo native coronary artery lesions”, Sponsor: Medtronic.

ADHERE — Longitudinal Module — Registry of Severe Heart Failure Patients at High Risk for Rehospitalization, Sponsor: Scios, August 2002.

ACUITY – “A randomized comparison of Angiomax (bivalirudin) versus Lovenox (enoxaparin) in patients undergoing early invasive management for acute coronary syndromes without STsegment elevation”, Sponsor: The Medicines Company, Protocol TMC-BIV-02-08, December 2003.

VALIANT-“Multinational, multi-center, double-blind, randomized, active controlled, parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril and their combination in high-risk patients after myocardial infarction”, Sponsor: Novartis, Protocol #CVAL489 0108, October 1999.

“A 24-week Randomized double-blind Multicenter Trial to Evaluate the Efficacy and Safety of Starting and Maximum Doses of ZD4522 and Atorvastatin in the Treatment of Subjects with Hypercholesterolemia and Documented Atherosclerosis”. Sponsor: Zeneca Pharmaceuticals, Protocol #4522IL-0025, September 1999.

2nd SYMPHONY – “A Phase III, multi-center, international, randomized, double-blind, aspirincontrolled trial to evaluate the efficacy and safety of two regimens with XubixTM (sibrafiban; Ro48-3657), an oral platelet glycoprotein IIb/IIIa receptor antagonist, as therapy for the long term prevention of secondary vascular events in patients after an Acute Coronary Syndrome.” Sponsor: Hoffman LaRoche, Protocol #BC15457, December 1998.

BRAVO – “Blockade of the GP IIB/IIIA Receptor to Avoid Vascular Occlusion”, Smith-Kline Beecham Pharmaceuticals, Protocol #SB 214857/030, May 1999.

PRESTO – “Prevention of Restenosis with Tranilast and Its Outcomes: A Placebo-Controlled Trial”, Smith-Kline Beecham Pharmaceuticals, Protocol #9952AA/004, 1999.

LIMIT AMI – “A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Angiographic Trial of the Safety and Efficacy of rhuMAb CD18 in Acute Myocardial Infarction” Sponsor: Genentech, Protocol #S0826g. SVA-4- “A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Design Clinical Trial to Assess the Efficacy and Safety of a Daily Oral Dose of 125 mg of Azimilide
Dihydrochloride for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Symptomatic Paroxysmal Supraventricular Tachycardia”, Sponsor: Proctor and Gamble, Protocol #1998017, July 1998.

SVA-4- “A Multi-Center, Open-Label Clinical Trial to Assess the Long-Term Safety of a Daily Oral Dose of 125 mg of Azimilide Dihydrochloride for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Symptomatic Paroxysmal Supraventricular Tachycardia”. Sponsor: Proctor and Gamble, Protocol #1998018, July 1998.
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RAFT- “A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Slow Release Propafenone (Rhythmol-SR) in the Prevention of Symptomatic Recurrences of Atrial Fibrillation”, Sponsor: Knoll Pharmaceuticals, Protocol #P-85-AF-8521, 1998.

ALIVE – “A Double-Blind, Placebo-Controlled, Parallel Design Study to Determine the Effect of 75 or 100 mg of Orally Administered Azimilide Dihydrochloride versus Placebo on Survival in Recent Post-Myocardial Infarction Patients at Risk of Sudden Death”, Sponsor: Proctor and Gamble, Protocol #1997017, Sept. 1997.

GUARDIAN- “A Double-Blind, Placebo-Controlled, Multi- National Trial to Investigate the effect of the Na+/H+ Exchange Inhibitor HOE 642 (Cariporide)on All-Cause Mortality and Myocardial Infarction in Patients at Risk of Myocardial Necrosis due to Acute Coronary Syndrome Related to the Disease Process or to an Interventional Procedure”, Sponsor: Hoechst Marion Rousell, Protocol #HOE642A/3001, April 1997.

ASSENT I — “A Phase II, Randomized, Open-Label, Parallel Group, Multi-Center, International Trial of the safety of TNK-tPA in Acute Myocardial Infarction (Assessment of the Safety of a New
Thrombolytic TNK-tPA) Sponsors: Genentech Inc., Protocol #N0683g & Boehringer Ingelheim, Protocol #1123.3, 1997.

SVA-3- “A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Design Clinical Trial to Assess the Efficacy and Safety of 50 mg, 100 mg, and 125 mg of Azimilide Dihydrochloride for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Symptomatic Paroxysmal Supraventricular Tachycardia”, Sponsor: Proctor & Gamble, Protocol #1996033, 1996.

SVA-3 – “A Multi-Center, Open-Label Clinical Trial to Assess the Long-Term Safety of 100mg. of Azimilide Dihydrochloride in Patients with Atrial Fibrillation /Flutter and/or Paroxysmal Supraventricular Tachycardia”, Sponsor: Proctor and Gamble Protocol #1996034, 1996.

SVA-2 – “A Multi-Center, Double-Blind, Placebo Controlled, Parallel Design Clinical Trial to Assess the Safety and Efficacy of 35 mg and 75mg of Azimilide Dihydrochloride for Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Paroxysmal Supraventricular Tachycardia”, Sponsor: Proctor and Gamble, Protocol #1995115, 1996.

SVA-2 – “A Multi-Center, Open-Label Clinical Trial to Assess the Long-Term Safety of 75 mg of Azimilide Dihydrochloride in Patients with Atrial Fibrillation/Flutter and/or Paroxysmal Supraventricular Tachycardia”, Sponsor: Proctor and Gamble, Protocol #1995116, 1996.

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