Research

Research Projects

Abbott Vascular: CHOICE Study. Jean Starr, M.D., Principal Investigator.  Carotid Stenting for High Surgical Risk Patients: Evaluating Outcomes Through the Collection of Clinical Evidence.  Primary Objectives: To provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. To provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services coverage to a broader group of patients.

Bolton Medical, Inc.: Relay Trial.  Patrick Vaccaro, M.D., Principal Investigator. A Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent Graft in Patients with Thoracic Aortic Pathologies.  Primary Objectives: Efficacy and safety.  Primary efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent Graft) though one year.  Primary safety will be evaluated by comparing major adverse events within one year in subjects treated using the Relay Thoracic Stent Graft with those who underwent open surgical repair.

Boston Scientific Corporation: SONOMA Study.  Jean Starr, M.D., Principal Investigator.  The NexStent® Carotid Stent System: A Post-Market Approval Evaluation Study in Conjunction with the FilterWire EZ™ Embolic Protection System.  Primary Objective: To confirm the safety of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that may occur with the use of this system.

Cleveland Clinic Foundation/Medtronic PIVOTAL Study. Jean Starr, M.D., Principal Investigator. PIVOTAL (Positive Impact of Endovascular Options for Treating Aneurysms Early) Study. Primary objective: To compare endovascular repair versus surveillance, with respect to patient survival, AAA rupture, and AAA-related death, and to determine whether the repair of small aneurysms (4-5 cm) using the AneuRx AAA Stent Graft is superior to serial imaging surveillance, with respect to frequent rupture or aneurysm-related death, over a three-year follow-up period. The project is awaiting Institutional Review Board approval.

Cook Zenith Study. Patrick Vaccaro, M.D., Principal Investigator. Zenith TX2 Thoracic TAA Endovascular Graft Clinical Study Protocol. Primary objective: To evaluate the safety and effectiveness of the Zenith TX2 Thoracic TAA Endovascular Graft in elective treatment of patients with descending thoracic aortic aneurysms (DTAA).

Cordis Corporation SAPPHIRE WW Study.  Jean Starr, M.D., Principal Investigator. Stenting And Angioplasty with Protection in Patients at High Risk for Endarterectomy.  Primary Objective: To estimate 30-day MAE rate of stenting distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies).

CVRx Rheos Trial.  Jean Starr, M.D., Principal Investigator.  CVRx Rheos Pivotal Trial.  Primary objective: To demonstrate the efficacy and safety of the Rheos system in subjects with stage II hypertension that is resistant to treatment with at least three antihypertensive agents, one of which is a diuretic.  This trial is being conducted as the pivotal trial for supporting the pre-market approval application to the FDA.