Clinical Trials

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

National Principal Investigator:  Marc Schermerhorn, MD
Purpose: The purpose of this trial is to determine the safety and effectiveness of IMPEDE-FX Rapid Fill System to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm (AAA) sac when it is used as an adjunct during endovascular aneurysm repair (EVAR) using FDA approved commercially available stent grafts subjects considered candidates for elective EVAR. The trial is a multicenter, randomized, pre-procedure single blind, open-label trial. The randomized trial will have two arms as described below:

• Treatment Arm: Subjects in the treatment arm will have both an EVAR device and also the IMPEDE-FX RapidFill Implants implanted
• Control Arm: Subjects in the control arm will only have an EVAR device implanted

Subjects in the treatment and control arms will be followed through 5 years post-procedure with visits at 30 days, 6 months, 1 year and annually thereafter through 5 years., for a total of 9 visits. At each visit a computed tomography angiography (CTA) and duplex ultrasound (DUS) will be required.

Clinical Trials.gov ID NCT06029660 

Physician-modified Endovascular Grafts (PMEG) in the Treatment of Complex Thoraco-Abdominal Aortic Pathology

National Principal Investigator:  Marc Schermerhorn, MD
Purpose: This is a single center study at BIDMC. The primary purpose of the study is to evaluate the safety and effectiveness of the physician-modified endovascular graft (PMEG) for the endovascular repair of complex aortic pathology, specifically, complex abdominal aortic aneurysms (AAAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic dissections. Approximately 50 patients will be enrolled in this study at BIDMC.

ROADSTER 3 Extended Follow-up Sub-Study

National Principal Co-Investigator:  Marc Schermerhorn, MD
Purpose: The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS). This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.

ADVANCE Trial in Sac Regression - Endurant Stent Graft System vs Excluder Endoprothesis

National Principal Investigator:  Marc Schermerhorn, MD
Purpose: This trial is designed as a post-market, prospective, interventional, non-blinded, global, multi-center, randomized (1:1), dual arm, clinical trial to generate clinical evidence to evaluate sac regression and other clinical outcomes and compare these outcomes between the Medtronic Endurant II/Endurant IIs and Gore Excluder/Excluder Conformable, in subjects with AAA indicated for an EVAR procedure. CT imaging will be performed at every follow-up visit, which follows the long-term surveillance recommendations of the Instruction for Use (IFU). CT imaging may not be considered normal clinical practice at each study site. It is anticipated that up to 30 subjects may be enrolled at BIDMC. The expected duration of each subject’s participation is up to 5 years after the index procedure with follow up visits and CTA at 1, 12 months and 2,3,4, 5 years after Initial procedure The trial is expected last 7 years.