Clinical, Pharmacologic and Device Trials

BASIC RESEARCH
PUBLICATIONS

For more information regarding these studies, call 414-649-3356.

Atherosclerotic Disease

TRA-2P
Study Sponsor: Schering Plough Research Institute
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events
Principal Investigator: Anjan Gupta, MD
Clinical Coordinator: Deb Seaton, RN

CRESCENDO
Study Sponsor: sanofi-aventis
Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20 mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors
Principal Investigator: Dianne Zwicke, MD
Clinical Coordinator: Deb Seaton, RN

COGENT I 
Study Sponsor: Cogentus Pharamaceuticals, Inc.
A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared with Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
Principal Investigator: Anjan Gupta, MD
Clinical Coordinator: Deb Seaton, RN

Atrial Septal Defects/Patent Foramen Ovale/Migraines

PREMIUM (PFO-Patent Foramen Ovale Closure for migraine headaches)
Study Sponsor: AGA Medical Corporation
Prospective Randomized investigation to Evaluate incidence of headache reduction in patients with Migraine and PFO Using the AMPLATZER PFO Occluder compared to Medical Management
Principal Investigator: Tanvir Bajwa, MD/Varun Saxena, MD
Clinical Coordinator: Deb Waller, RN, CCRC

PFO ACCESS REGISTRY (Patent Foramen Ovale Closure)
Study Sponsor: AGA Medical Corporation
Patent Foramen Ovale Closure with the AMPLATZER PFO Occluder in Patients with Recurrent Cryptogenic Stroke due to Presumed Paradoxical Embolism through a Patent Foramen Ovale and who have Failed Conventional Drug Therapy
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Deb Waller, RN, CCRC

CLOSURE 1
Study Sponsor: NMT Medical, Inc
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex Septal Closure System Versus Best Medical Therapy in Patients with a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Oval
Principal Investigator: Varun Saxena, MD/Tanvir Bajwa, MD
Clinical Coordinator: Deb Waller, RN, CCRC

Carotid Disease

PROTECT
Study Sponsor: Abbott Vascular Solutions
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

CHOICE
Study Sponsor: Abbott Vascular Solutions
Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

SAPPHIRE
Study Sponsor: Cordis Corporation
Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

ACT I
Study Sponsor: Abbott Vascular Devices
A randomized, controlled trial to demonstrate the equivalence (non-inferiority) of carotid artery stenting (CAS) using the Xact RX Carotid Stent System with the Emboshield Cerebral Protection System, compared to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid occlusive disease.
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

EMPIRE 
Study Sponsor: W.L. Gore & Associates, Inc.
The Embolic Protection with Reverse Flow (EMPIRE) Study of the GORE Neuro Protection System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy.
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

Congestive Heart Failure

PRECEDE
Study Sponsor: Medtronic
Prospective, Randomized, Evaluation of Cardiac Compass in the Early Detection of Decompensation Events for Heart Failure
Principal Investigator: Masood Akhtar, MD
Clinical Coordinator: Anthony Chambers, RN

REDUCE HF
Study Sponsor: Medtronic
Medtronic Chronicle® ICD Implantable Cardioverter Defibrillator
Principal Investigator: Edward Hastings, MD
Clinical Coordinator: Anthony Chambers, RN

SLS (ICD Monitoring Registry)
Study Sponsor: Medtronic, Inc
System Longevity Study
Principal Investigator: Masood Akhtar, MD
Clinical Coordinator: Anthony Chambers, RN

Coronary Disease

PERSEUS SMALL VESSEL
Study Sponsor: Boston Scientific Corporation
A Prospective Evaluation in a non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Don Lobacz, RN, CCRC

PERSEUS WORKHORSE
Study Sponsor: Boston Scientific Corporation
A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Don Lobacz, RN, CCRC

CYPHER ELITE
Study Sponsor: Cordis, a Johnson & Johnson Company
A Prospective, Single Blind, Randomised, Multi-Center, Study Comparing The CYPHER® ELITE™ to The CYPHER® Bx VELOCITY™ Sirolimus-Eluting Stent Systems 
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Wendy Schmidt, RN, CCRC

Peripheral Vascular Disease

CLI (Chronic Limb Ischemia)
Study Sponsor: Baxter
Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects with Moderate or High-Risk Critical Limb 
Principal Investigator: Steven Port, MD
Clinical Coordinator: Don Lobacz, RN, CCRC

VIPER
Study Sponsor: W.L. Gore and Associates
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Anthony Chambers, RN

STROLL
Study Sponsor: Cordis Corporation
S.M.A.R.T™ Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
Principal Investigator: Tanvir Bajwa, MD
Clinical Coordinator: Anthony Chambers, RN

Pulmonary Hypertension

POWER 15 (Evaluation of drug inhalation system)
Study Sponsor: CoTherix, Inc
A Comparison of Safety and Inhalation Times of Iloprost Delivered by I-Neb utilizing Power Disc 6 and Power Disc 15
Principal Investigator: Ramagopal Tumuluri, MD
Clinical Coordinator: Don Lobacz, RN, CCRC  

FREEDOM
Study Sponsor: United Therapeutics Corp
(1) A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5. A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled
(2) Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension.  TDE-PH-302
Associated with the above Protocol: Protocol TDE-PH-307:  An Evaluation of Biomarkers and Genetics in Subjects with Pulmonary Arterial Hypertension Inhibitor in Subjects with Pulmonary Arterial Hypertension.
(3) An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension 
(4) Protocol TDE-PH-307: An Evaluation of Biomarkers and Genetics in Subjects with Pulmonary Arterial Hypertension
Principal Investigator: Dianne Zwicke, MD
Clinical Coordinator: Don Lobacz, RN, CCRC

ATHENA-1
Study Sponsor: Gilead Sciences, Inc
A Randomized, Multicenter Study of Ambrisentan and Sildenafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension who have Demonstrated a Sub-Optimal Response to Sildenafil
Principal Investigator: Dianne Zwicke, MD
Clinical Coordinator: Don Lobacz, RN, CCRC 

PROWESS 301 and 302
Study Sponsor: Actelion Pharmaceuticals Ltd
301: A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension
302: A Multicenter, Double-blind, Randomized Study to Compare the Safety and Tolerability of Inhaled Iloprost Delivered by I-neb using Power 15 disc and Power 6 disc in Patients with Symptomatic Pulmonary Arterial Hypertension
Principal Investigator: Dianne Zwicke, MD
Clinical Coordinator: Don Lobacz, RN, CCRC  

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