Vascular Clinical Trials

stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy

Purpose: This study will measure the usefulness of a new investigational treatment, which could potentially slow the growth of small to mid-sized AAA. The new investigational treatment, called the Nectero EAST System, uses an investigational product called pentagalloyl glucose (PGG). This is a prospective, randomized, controlled, multi-center, clinical trial that  will enroll and randomize 400 subjects, at up to 50 sites. Patients will be in this research study for 5 years and will include approximately 8-9 study visits at Beth Israel Deaconess Medical Center.

Principal Investigator:  Marc Schermerhorn, MD
Research Nurse: Su Huang, RN

Zenith Fenestrated+ Endovascular Graft Clinical Study Global Clinical Number 17-07 Z- FEN PLUS

Purpose: The objective of this study is to evaluate the safety and effectiveness of the Investigational Zenith Fenestrated+ Endovascular Graft (ZFEN+) for the treatment of patients with aortic aneurysms, when the device sealing zone requires fenestrations with connections to one or more of the major visceral arteries.

Principal Investigator: Marc Schermerhorn, MD
Research Nurse: Su Huang, RN

IMPROVE AD

Purpose: The purpose of this study is to evaluate treatment of a type B aortic dissection. The goal of this study is to figure out the best way to treat this condition. Patients will be assigned to one of 2 groups. Group 1 will have a less invasive procedure called thoracic endovascular aortic repair (TEVAR) and receive medicine.

Group 2 will receive medicine and watched for problems. Both groups represent acceptable care for type B aortic dissection.  It is unclear which treatment is better. Participation will last up to 6 years, with regular visits and CT scans at BIDMC at 1 and 6 months, then yearly x 5 years.

Principal Investigator:  Marc Schermerhorn, MD
Research Nurse: Su Huang, RN

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

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.

Principal Investigator and Global PI: Marc Schermerhorn, MD
Research Nurse: Mary Trovato, RN
Project Manager: Su Huang, RN

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

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.

Principal Investigator: Marc Schermerhorn, MD
Aortic Center Coordinator:  Theresa Bishop, RN, BSN
Back up Study Coordinator: Mary Trovato, RN, BSN

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE Trial)

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. 

Principal Investigator and National PI: Marc Schermerhorn, MD
Secondary Coordinator: Su Huang, RN

STABILISE Registry

Purpose: The aim of the study is to evaluate results of patients treated with the Stabilise technique for Acute/subacute aortic dissection. Approximately 10 people will take part in this study at BIDMC. A total of 200 people will take part in the study at up to 50 centers throughout the world.

Principal Investigator: Marc Schermerhorn, MD
Coordinator: Mary Trovato, RN, BSN