Division of Vascular Diseases and Surgery

Pedram Ghafourifar, Ph.D., is research associate professor of surgery and director of basic science research in the Division of Vascular Diseases and Surgery. Dr. Ghafourifar’s lab is studying molecular mechanisms underlying vascular diseases, particularly those involving oxidant free radicals, nitrogen oxides, mitochondria, and apoptosis machinery. His lab is also studying novel mechanisms involved in pharmacological effects of drugs affecting vascular smooth muscle and endothelial cells, as well as blood elements. Dr. Ghafourifar’s studies use advanced spectroscopy, proteomics, genetics, and enzymology.

Cleveland Clinic Foundation/Medtronic: The PIVOTAL Study: Positive Impact of Endovascular Options for Treating Aneurysms Early. Jean Starr, M.D., Principal Investigator. 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. This project continues to enroll eligible patients.

Cook Zenith Study: Zenith TX2 Thoracic TAA Endovascular Graft Clinical Study. Patrick Vaccaro, M.D., Principal Investigator. 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. Enrollment remains open on this study.

Gore-Tex Propaten Study: Comparison of Primary Patency between Gore-Tex Propaten Vascular Grafts and Thin-Walled Gore-Tex Stretch Vascular Grafts. Patrick Vaccaro, M.D., Principal Investigator. Primary objective: To demonstrate equivalence in patency performance of Gore-Tex Propaten Vascular Grafts and Thin-Walled Gore-Tex Stretch Vascular Grafts in a peripheral bypass application, to support a claim of substantial equivalence. Enrollment is closed on this study.

Guidant CAPTURE Study. A Post-Approval Study of the Guidant Carotid Stent System and Embolic Protection Systems. Jean Starr, M.D., Principal Investigator. Primary objective: To collect data on the Acculink and Accunet, when used by a broad group of physicians under commercial-use conditions, to support the following specific goals: Confirm that the Acculink Carotid Stent System and the Accunet EPS can be used safely by physicians with varying levels of experience, and identify rare or unanticipated device-related events that might occur with the use of the Acculink Carotid Stent System and Accunet EPS. Enrollment is now closed on this study.

National Institute on Aging (AG023264-03). Pedram Ghafourifar, Ph.D., Principal Investigator. Heart Mitochondrial NOS and In Vitro Hypoxia/Reperfusion.

American Heart Association (AHA 0565221B) Pedram Ghafourifar, Ph.D., Principal Investigator. Mitochondrial NOS and Hypoxia/Reoxygenation.

Abbott Vascular CHOICE Study. Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes through The Collection of Clinical Evidence. Jean Starr, M.D., Principal Investigator. Primary objective: To provide a mechanism for collection of data from Abbott Vascular’s Carotid Stent Systems and Embolic Protections Systems (Acculink/Accunet System and Xact System/Emboshield System) when used by a broad group 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. Final IRB approval has been received, and the study will soon be enrolling patients.

Bolton Medical: Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients with Thoracic Aortic Pathologies. Patrick Vaccaro, M.D., Principal Investigator. Primary Objectives: (1) Primary efficacy to be evaluated by the device-related adverse event rate of endovascular repair via Relay Thoracic Stent Graft through one year; (2) Safety will be evaluated by comparing major adverse events through one year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent open surgical repair. Final IRB approval has been received, and the study will soon be enrolling patients.

Cordis Corporation SAPPHIRE WW. SAPPHIRE WW Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy. Jean Starr, M.D., Principal Investigator. Primary Objectives: To estimate the 30-day major adverse event rate of stenting (any death, stroke, or MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical-risk patients with atherosclerotic disease of the carotid artery using the Cordis PRECISE Nitinol Stent Systems and the Cordis Angioguard XP Emboli Capture Guidewire. Final IRB approval has been received, and enrollment will start soon.

Boston Scientific Corporation SONOMA: The NexStent Carotid Stent System: A Post-market Approval Evaluation Study in Conjunction with the FilterWire EZ Embolic Protection System. Jean Starr, M.D., Principal Investigator. 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. Final IRB approval is pending for this study.

Operative Treatment of Thoracic Outlet Syndrome. Patrick Vaccaro, M.D., Jeffrey Henke, Investigators. Primary Objective: A retrospective review of all cases of Thoracic Outlet Syndrome (TOS) treated by first rib resection between January 1995 and January 2006. Operative outcomes and the factors that may influence those outcomes are the primary focus of this study.

An Analysis of Endograft Migration with AneuRx Aortic Stent Graft. Jean Starr, M.D., Richard Fries, M.D., Investigators. Primary Objective: To retrospectively review the incidence of AneuRx stent graft migration at Ohio State University Medical Center and to examine the variables that may contribute to increased migratory rates.

Bovine Patch Angioplasty during Carotid Endarterectomy: A Retrospective Review. Jean Starr, M.D., Irina Pleister, M.D., Investigators. Primary Objective: To review the data regarding demographics, operative indications, perioperative complications, midterm complications, and most important, the occurrence of late adverse outcomes of bovine pericardial patch angioplasty during CEA at Ohio State University Medical Center.

Complications with the Angio-Seal and StarClose Endovascular Closure Devices: A Retrospective Review. Jean Starr, M.D., Ryan Helmick, Investigators. Primary Objective: To review the patient characteristics, method of closure, and outcomes, including complications, of patients receiving peripheral angioplasty for heart catheterization and closure with either manual compression, Angio-Seal, or StarClose devices at Ohio State University Medical Center.

Natural History of Great Saphenous Vein Stump following Endo-Venous Laser Therapy. Bhagwan Satiani, M.D., Irina Pleister, M.D., Investigators. Primary Objective: Compile data regarding the natural history of the GSV stump and its potential as a complication involved in postoperative deep venous thrombosis and pulmonary embolus.

Distaflo Grafts and Long-term Outcomes: A Retrospective Review. Blair Vermilion, M.D., Clinton Hall, M.D. Investigators. Primary Objective: To review the patient characteristics, method of bypass, and outcomes, including patency and complications, of patients undergoing lower extremity bypass with Distaflo grafts.