News & Stories

Through groundbreaking clinical trials, the Cooper Aortic Center brings devices that are pending FDA approval to patients right now making dramatic differences in patient outcomes. Here is a snapshot of current clinical trials:

Zenith TX2® TAA Endovascular Graft Post-market Approval Study-
Principal Investigator: Francis Caputo, MD
This study evaluates the long-term safety and performance of the Zenith® TX2 TAA Endovascular Graft in the elective treatment of patients with descending thoracic aortic aneurysms or ulcers.

CONTINUUM: Infra-Inguinal Stenting Using the Bard LifeStent® Vascular Stent Systems
Principal Investigator: Jeffrey P. Carpenter, MD
This study is a prospective, multi-center, single-arm, non-randomized study enrolling subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesions in the infra-inguinal segment (superficial femoral artery and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty and stenting.

FREEDOM: GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Principal Investigator: Jeffrey P. Carpenter, MD
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE® Flow Reversal System and the GORE® Embolic Filter when used for embolic protection during carotid artery stenting.

HARVEST: Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate for the treatment of Critical Limb Ischemia due to Peripheral Arterial Occlusive Disease
Principal Investigator: James Alexander, MD
The purpose of this pivotal study is to provide clinical data demonstrating the safety and effectiveness of a concentrate of nucleated cells from bone marrow aspirate produced with the Harvest Bone Marrow Aspirate Concentrate System for treating lower limbs of patients diagnosed with critical limb ischemia due to peripheral arterial occlusive disease.

STABLE II: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection
Principal Investigator: Francis Caputo, MD
The objective of the study is to evaluate the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with complicated, type B aortic dissection.

INSPIRATION: A Multicenter, Open Label, Prospective, Non-Randomized Study of the INCRAFT™ Stent Graft System in Subjects with Abdominal Aortic Aneurysms
Principal Investigator: Joseph V. Lombardi MD
The purpose of this study is to evaluate the safety and effectiveness of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair.