Vascular Clinical Trials

A World Leader in Vascular Clinical Trials

The Division of Vascular and Endovascular Surgery at BIDMC is among the most active vascular clinical trial sites in the world, providing patients with access to expanded therapies and new treatment options.

The Division of Vascular and Endovascular Surgery in Beth Israel Deaconess Medical Center's CardioVascular Institute is among the most prolific vascular clinical trial sites in the world, offering patients expanded treatment options that might include new drugs, devices and procedures. Below is a list of active clinical trials in BIDMC's Division of Vascular and Endovascular Surgery. Your surgeon will discuss whether there is a clinical trial that is appropriate for you.

For more information, please contact Mary Trovato, RN, BSN

Aortic Disease

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

Performance of the Gore Excluder Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysm

Purpose: The purpose of this study is to assess the safety and effectiveness of the CEXC Device for the treatment of infrarenal AAA endovascular treatment in subjects with aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥ 10 mm. Approximately 5 individuals will take part in this study at BIDMC Boston. There will be approximately 248 individuals enrolled in the study across North America.

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

Relay Pro Transection

Purpose: The purpose of the RelayPro clinical trial is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Graft System in subjects with traumatic injury of the descending thoracic aorta (DTA). Approximately five people will take part in this study at BIDMC. A total of 50 people will take part in the study at up to 45 centers throughout the United States.

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

Using Smartphone Applications to Improve Patient Care

Purpose: The purpose of this study is to improve patient satisfaction scores after Endovascular Aortic Repair at Beth Israel Deaconess Medical Center (BIDMC) through the use of Smartphone technology called Patient Journey providing patient information as compared to the standard of care, patient education through the use of paper patient fact sheets.

This is a single center study that will enroll 100 patients

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

STABILISE Registry

A physician-initiated, international, multi-center, prospective and retrospective, non-randomized, observational registry of patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique.

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

Carotid Artery Stenosis

CREST-2

CREST-2 is an NIH-sponsored multi-center, randomized clinical trial. The main purpose of the study is to find out if the incidence of stroke or death is different or the same between subjects with carotid artery disease who receive medical management alone compared with subjects who receive medical management in combination with carotid endarterectomy (CEA) or carotid artery stenting (CAS). Approximately 20 individuals will take part in this study at BIDMC in Boston. There will be approximately 2,480 individuals enrolled in the study across North America.

Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking and other vascular risk factors. This trial will enroll patients who have known carotid artery disease but who have not suffered a stroke or mini-stroke. The vascular surgery and cardiology groups at BIDMC are jointly participating in this clinical trial.

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

Abbott BTK Randomized Trial

Purpose: The objective of this clinical investigation is to evaluate the safety and efficacy of the Investigational ESPRIT BTK, stent compared to Standard treatment PTA, in the planned treatment of diseased infrapopliteal lesions in patients with critical limb ischemia with up to two blockages in native blood vessels (de novo lesions) or restenotic (prior PTA lesion in separate vessels.

Approximately 10-15 individuals will take part in this study at BIDMC. A total of 225 individuals will take part in this study at all sites. Participants will have been diagnosed with peripheral artery disease (PAD), which has caused CLI.

Principal Investigator: Marc Schermerhorn, MD
Coordinator: Theresa Bishop, RN, BSN

Critical Limb Ischemia

Peripheral Artery Disease (PAD) and Critical Limb Ischemia

PAD is a condition that causes decreased circulation/blood flow to the legs. PAD can lead to critical limb ischemia (CLI), a condition in which arteries that deliver blood to the leg and foot become narrowed or blocked by plaque buildup (atherosclerosis). This condition limits the blood flow to the lower extremities and can cause pain in the feet or legs, even when a person is sitting or at rest. It can also cause the development of foot and leg ulcerations, and can sometimes lead to the loss of the leg.

CLI is usually treated by surgeries or procedures that increase blood flow to the feet and legs in order to relieve symptoms heal ulcers and preserve limbs. There are two different ways to increase blood flow in cases of CLI. One is with open surgery, in which a bypass is created around the blockage. The second is with an endovascular treatment, often called an angioplasty, a minimally invasive procedure that is performed through a catheter inserted into the skin to directly open blocked arteries. Angioplasty is performed with balloons and other tools that clear the plaque. Sometimes small, mesh-like metal tubes called stents are permanently implanted. Both types of treatment are appropriate for CLI patients.

A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard UltraScore Focused Force PTA Balloon

Purpose: The objective of this study is to assess the clinical use of the FDA approved Bard UltraScore Focused Force PTA for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries.

Approximately 25 individuals will take part in this study at BIDMC. A total of 350individuals will take part in this study at all sites. Participants will have been diagnosed with peripheral artery disease (PAD), which has caused CLI.

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

BEST Registry

The purpose of this study is to develop a survey (questionnaire) for patients with peripheral arterial disease and critical limb ischemia that can be used to provide information to their doctors or health-care providers about their values and treatment preferences. Approximately 10 people will take part in this study at BIDMC. A total of 50 people will take part at study sites across the United States.

Principal Investigator: Allen Hamdan, MD
Coordinator: Mary Trovato, RN, BSN

Additional Trials

Feasibility Study of the Philips 3D Ultrasound Sound System during Peripheral Vascular Interventions using Angiography

Purpose: This is a single center Pilot Study using the FDA approved Philips 3D XL14-3 ultrasound probe and EPIQ 7System, in conjunction with angiographic imaging during peripheral vascular interventions, to potentially improve procedure success and/or reduce radiation/contrast usage. The 3D Ultrasound may improve understanding of lesion location, dimension, morphology and allow better assessment of treatment success, with improved ease of use compared to 2D ultrasound, eliminating the need for an expert sonographer

Up to 10 subjects will be enrolled at BIDMC.

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