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Cardiac
CAP: Continued Access to PROTECT AF Registry
Sponsored by Atritech, Inc.
Atrial Fibrillation is a heart condition in which the upper chambers of one's heart beats too fast. This condition can cause blood to pool and form clots in an area of the heart called the left atrial appendage. Current treatment is to take blood-thinning medications that reduce the risk of stroke or related complications, but requires frequent blood draws to monitor bleeding. The WATCHMAN left atrial appendage system is implanted permanently in your heart through an angioplasty procedure without the need to take blood thinning medications.
Principal Investigator: Ramon Quesada, M.D.
EVEREST II : Endovascular Valve Edge-to-Edge REpair STudy II
Sponsored by: Evalve, Inc.
Mitral Regurgitation (MR) occurs when the leaflets (or flaps) of the heart’s mitral valve do not close properly and leak. During pumping, the leak causes blood to flow backwards (MR) into the left atrium, thereby decreasing blood flow to the body. The purpose of the EVEREST II trial is to assess the safety and efficacy (or effectiveness) of the Evalve Procedure in treating patients diagnosed with Grade 3 (moderate to severe) or Grade 4(severe) mitral regurgitation MR, as compared to surgical repair of mitral regurgitation (MR).
Principal Investigator: Ramon Quesada, MD
Co-Investigators: Barry Katzen, MD
Niberto Moreno, MD
Rafael Machado, MD
Luis A De La Cruz Abramo, MD
Joseph Lamelas, MD
CLOSURE1: Evaluation of the STARFlexÒ Septal Closure System in Patients with a Stroke and/or transient ischemic attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale
Sponsored by NMT Medical, Inc.
The primary objective of this study is to determine whether the STARFlexÒ Septal Closure System (STARFlex) will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) in patients with a patent foramen ovale (PFO) and to compare the STARFlex device to best medical therapy.
Principal Investigator: Paul Damski, MD
Co-Investigators: Ramon Quesada, MD
Allan Herskowitz, MD
Brad Herskowitz, MD
Bernard Gran, MD
Steven Kobetz, MD
David Racher, MD
CHAMPION: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NHA Class III Heart Failure Patients
Sponsor: CardioMEMS, Inc.
The purpose of this study is to evaluate the benefits of the use of the HF Pressure Measurement System in the treatment of heart failure subjects in reducing hospitalizations related to the disease process. This is a prospective, multi-center, randomized, single-blind clinical trial. There will be up to 70 patients enrolled in the United States at as many as 20 clinical sites. At BCVI approximately 14 patients may be enrolled.
Principal Investigator: Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
Patent Foramen Ovale ( PFO) Closure
CARS Evaluation of closure of a patent foramen ovale (PFO) using the STARFlex Septal Repair System in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale who have failed conventional drug therapy (CARS-Closure After Recurrent Stroke)
Sponsored by NMT Medical, Inc.
This is a clinical registry using the STARFlex Septal Repair System in subjects with recurrent cryptogenic strokes due to presumed embolic activity through a patent foramen ovale (PFO) and who have failed conventional anticoagulant drug therapy. This registry has open enrollment and up to 100 sites participating.
Principal Investigator: Ramon Quesada, M.D.
A Clinical Trial comparing Cangrelor to Clopidogrel in subjects who require Percutaneous Coronary Intervention
Sponsored by The Medicines Company
This is a drug study comparing an investigational drug Cangrelor to Clopidogrel (Plavix®) to prevent blood clots in subjects having a procedure to treat the blood vessels in the heart.
Principal Investigator: Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
SWITCH III: Switching from ArixtraÒ (fondaparinux to AngiomaxÒ (bivalirudin) or unfractionated heparin in patients with acute coronary syndromes without ST-segment elevation undergoing percutaneous coronary intervention (PCI)
Sponsored by: Cardiovascular Research Institute
This study is being done to find out if patients with Acute Coronary Syndrome could benefit from receiving an anticoagulant such as Arixtra® prior to angioplasty. The use of Arixtra® prior to administration of Angiomax® (bibalirudin) or unfractioned heparin during angioplasty is an experimental procedure (not FDA approved).
Principal Investigator: Ramon Quesada, MD
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
Sponsor: Abbott Cardiovascular Systems, Inc.
This is a data collection research study to evaluate the continued safety and effectiveness of the XIENCE™ V Everolimus Eluting Coronary Stent System (the XIENCE V EECSS) recently approved for use by the Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries (blood vessels in the heart). The Study is being conducted to only collect information post stenting. Those who participate in the study will be asked to complete the Seattle Angina Questionnaire at 6 months and 1 year and inquire about current medical condition after one receives the XIENCE™ V Everolimus Eluting Coronary Stent System.
Principal Investigator: Ramon Quesada, MD
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
Carotid Stenosis
ACT I (Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients)
Sponsored by Abbott Vascular Devices
The study is being conducted to demonstrate the difference in patient outcomes between carotid artery stenting (CAS) - using the Xact Rapid Exchange Carotid Stent System in conjunction with the emboshield Cerebral Protection System (interventional) - and the surgical procedure of carotid endarterectomy (CEA), for the prevention of strokes in patients who have extracranial carotid stenotic disease who do not present clinical symptoms (asymptomatic).
Principal Investigator: Barry Katzen, M.D.
Co-Investigator: Gerald Zemel, M.D.
Surgeons: Athanassios Tsoukas, M.D.; OrlandoPuente, M.D.
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
Sponsored by W. L. Gore & Associates, Inc.
This study will offer the use of the GORE Neuro Protection System during a carotid stenosis stenting procedure. The reversal of blood flow of this system will prevent particles that may break off during the procedure from entering the brain. About 300 subjects will be enrolled in this study.
Principal Investigator: Barry Katzen, M.D.
Co-Investigator: Gerald Zemel, M.D., James Benenati, M.D.
(ARMOUR)ProximAl pRotection with the Mo.Ma™ Device dUring caRotid stenting
Sponsored by Invatec LLC
The purpose of this study is to demonstrate that the Mo.Ma ™ Cerebral Protection Device is safe and effective when used with FDA approved stents for carotid artery stenting. The Mo.Ma Device is an experimental device. The study will collect information on as many as 303 patients. At BCVI approximately 25 patients will be enrolled in the study.
Principal Investigator, James Benenati M.D.
Co-Investigator: Gerald Zemel, M.D., Barry Katzen, M.D.
(SAPPHIRE WW) Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
Sponsored by Cordis Corporation
This post-market global study is a registry to evaluate the use of a carotid stent PRECISE®Nitinol Stent System and the ANGIOGUARD™XP emboli Capture Guidewire in patients of high-surgical risk with atherosclerotic disease of the carotid artery.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D. , James Benenati, M.D.
Abdominal and Thoracic Aortic Aneurysms
Relay II (A Phase II Clinical Study of the Safety and Efficacy of the Relay™Thoracic Stent-Graft in Patients with Thoracic Aortic Pathologies)
Sponsored by Bolton Medical, Inc.
Relay is a phase II, multicenter, non-blinded, non-randomized study to evaluate the safety and performance of the Relay Thoracic Stent Graft for thoracic aortic aneurysms. Approximately 120 subjects will be enrolled at 25 sites. It also has a data collection part for patients needing surgery.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D.; James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.
Aptus The Pivotal Study of the Aptus Endovascular AAA Repair System Protocol
Sponsored by Aptus Endosystems, Inc
The Aptus Clinical Study is an investigational study to evaluate the safety and effectiveness of the Aptus™ Endovascular AAA Repair System for treating abdominal aortic aneurysms, or aorto-iliac aneurysms. The study will last approximately 5 years. The Aptus AAA Endograft is designed specifically for use with the Aptus EndoStaple System, which is designed to provide secure fixation of the endograft to the vessel wall.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D.; James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.
Clinical study to allow the use of the Endologix 34mm Powerlink Cuff for Continued Access.Sponsored by Endologix, Inc.
The study Sponsor Endologix, has recently designed a larger diameter device for use in patients with specific anatomical aneurysms. This study involves research to evaluate the use of a larger extension cuff in combination with the commercially available device to seal and prevent leaks at of aneurysms.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D.; James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.
Aorfix™ AAA stent graft: PYTHAGORAS: Prospective aneurYsm Trial: High AnGle Aorfix™ bifurcAted Stent graft.
Sponsored by Lombard Medical Technologies
This trial is intended to demonstrate the safety and use of the Aorfix™ device in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms in anatomy where the aorta in the neck of the aneurysm is bent through an angle of between 0° and 90°.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D.; James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.
Peripheral
DURABILITY II: The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II
Sponsored by ev3 Endovascular, Inc. (ev3)
The purpose of this study is to collect information and to find out if the use of the EverFlex Stent is more safe and effective than angioplasty when used in the leg above the knee. The study will collect information on about 287 patients. The EverFlex Stent, as it is used in this study, is an experimental device.
Principal Investigator: Barry Katzen, M.D.
Co-Investigators: Gerald Zemel, M.D.; James Benenati, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.
Zilver PTX II: Evaluation of the Zilver®PTX Vascular Stent in the Above-the Knee Femoropopliteal Artery
Sponsored by Cook Incorporated
This trial is to evaluate the Zilver® PTX™ Drug‑Eluting Vascular Stent for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery. Patients meeting the inclusion/exclusion criteria will be randomly assigned to either the Zilver® PTX™ Drug-Eluting Vascular Stent group or the Percutaneous Transluminal angioplasty (PTA) Control group. The length of the study is five years.
Principal Investigator: James Benenati, M.D.
Co-Investigators: Gerald Zemel, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.; Barry Katzen, M.D.
Stride I (Does Early Safe Thrombus Removal in DVT have an effect on patient outcomes?)
Sponsored by Bacchus Vascular, Inc.
Stride I is a study combining clot-busting (thrombolytics) drugs and blood thinners in the treatment of deep vein thrombosis. The clot busting drugs are delivered directly into a vein through a catheter to break up the clots resulting in faster relief from leg pain or swelling. The purpose of this study is to evaluate whether the addition of clot-busting or giving standard blood thinner therapy is potentially better treatment for patients with deep vein thrombosis.
Principal Investigator: James Benenati, M.D.
Co-Investigators: Gerald Zemel, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.; Barry Katzen, M.D.
Renal
A Prospective, non-randomized, multi-center, single-arm clinical trial to assess the safety and efficacy of the RX Herculink®Elite™Renal stent system for the treatment of suboptimal post-procedural percutaneous transluminal angioplasty(PTA)in atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
Sponsored by Abbott Vascular
The Study is a non-randomized trial to look at the safety of the RX Herculink Elite Renal Stent for the treatment of renal artery stenosis or restenosis in patients with uncontrolled hypertension (high blood pressure).
Principal Investigator: Gerald Zemel, M.D.
Co-Investigators: Barry Katzen, M.D.; Alex Powell, M.D.; Shaun Samuels, M.D.; Constantino Pena, M.D.; James Benenati, M.D |