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.

Aortic Disease

ANCHOR Registry

Purpose: This study is intended to expand the clinical knowledge base on the use of the HeliFX Aortic Securement System by including “real world” use over a broad spectrum of geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection criteria. The registry study will collect data regarding the use of the FDA approved HeliFX Aortic Securement System. Two thousand subjects will be enrolled at up to 75 sites. Up to 30 subjects will be enrolled at BIDMC.
More information

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

RELAY PRO

A thoracic aortic aneurysm (TAA) is a weakening and bulging of the thoracic aorta. This is the body's main blood vessel, which carries blood away from your heart to all parts of the body. A disease called atherosclerosis — in which fatty material accumulates under the inner lining of the heart's arterial wall — is often responsible for true aneurysms. Penetrating ulcers (PAUs) are lesions associated with aortic wall thickening and appear similar to saccular aneurysms (sac-like bulging) on x-rays. If left untreated, an aneurysm or ulcer can enlarge and rupture, posing a dangerous, life-threatening situation.

This clinical trial is investigating the safety and effectiveness of the Relay PRO Thoracic Stent Grafts in subjects with aneurysms (TAA) and penetrating ulcers (PAU) within the descending thoracic aorta.

Approximately five to 10 people will take part in this study at BIDMC. A total of 110 people will take part in the study at up to 45 centers throughout the United States.

Principal Investigator: Marc Schermerhorn, MD
Coordinator: Theresa Bishop, RN, BSN; 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.
More information

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

ROADSTER-2

Purpose: This study aims to establish the safety and effectiveness of the ENROUTE Transcarotid Neuroprotection System in providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries in subjects at high risk for complications. Approximately 40 individuals will take part in this study at Beth Israel Deaconess Medical Center in Boston. A total of 600 individuals will take part in this study at sites across the United States.

Participation in the study will be offered to patients whose carotid arteries — the arteries in the neck that supply blood to the brain — are significantly narrowed. Narrowed carotid arteries can lead to stroke or short-lived blindness. It has been shown that widening the narrowed portion of the artery may reduce the risk of a future stroke. This narrowing can be treated with a non-surgical procedure called transcarotid artery revascularization (TCAR). During TCAR, a stent (small metal tube) is placed in the artery by way of a surgical procedure called carotid endarterectomy (CEA) or by way of medical therapies including medications and management of risk factors. As part of this study, patients will be evaluated and treated with the TCAR procedure and a carotid artery stent.
More information

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

 

Peripheral Artery Disease 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.

BEST CLI

Purpose: The main purpose of this study is to learn which therapy — open surgery treatment or endovascular treatment — is most suitable for patients with Critical Limb Ischemia (CLI). This study is funded by the National Institutes of Health (NIH) and the National Heart, Lung, Blood Institute (NHLBI). The study will also gain information regarding cost effectiveness of the two different treatment types.

Approximately 20 individuals will take part in this study at Beth Israel Deaconess Medical Center. A total of 2,100 individuals will take part in this study at all sites. Participants will have been diagnosed with peripheral artery disease (PAD), which has caused CLI. More information

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

Pilot Study to Develop a Survey Tool for Critical Limb Ischemia Patients

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 U.S.

Principal Investigator : Raul Guzman, MD
Coordinator: Mary Trovato, RN, BSN

BTK: Lutonix Drug Coated Balloon Vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries

The purpose of this research study is to investigate whether the treatment of narrowed leg blood vessels below the knee with the Lutonix Drug Coated Balloon Catheter is safe and beneficial. This study has been approved by the U.S. Food & Drug Administration (FDA) and Beth Israel Deaconess Medical Center.

Approximately 30 to 40 individuals will take part in this study at Beth Israel Deaconess Medical Center. Up to 840 "randomized" patients will take part in this study worldwide. Balloon catheters are commonly used to expand narrowed blood vessels. These devices are made up of a very small balloon attached to the end of a thin tube. Lutonix has developed a balloon catheter that is similar in shape and size to other small balloon catheters except that the balloon is coated with a drug called paclitaxel. The Lutonix Durg Coated Balloon Catheter used in this study is an investigational device and is not approved for commercial use in the U.S. in leg arteries below the knee. The Lutonix Drug Coated Balloon catheter is approved in the U.S. for leg arteries above the knee.
More information

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

 

Venous Disease

Vernacular Venovo Stent Trial

The objective of this study is to assess the safety and effectiveness of the BARD VENOVO Venous Stent for the treatment of iliofemoral occlusive disease including Acute or Chronic Deep Vein Thrombosis (DVT), May-Thurner Syndrome or any combination of these. This is a prospective, multi-center, non-randomized, single-arm clinical study of the BARD VENOVO Venous Stent for the treatment of iliofemoral occlusive disease.

Subjects with a blockage or occlusion in the common and/or external iliac and/or common femoral veins (located in the abdomen and pelvis) being treated with a stent are eligible to participate. The stent is implanted into a vein at the spot where the narrowing or occlusion occurs. The narrowing or occlusion is opened with the stent and after the procedure is completed the stent remains in the vein.

Approximately 20 people will take part in this study at BIDMC. A total of 170 people will receive the study stent while it is expected that up to 340 people will take part in this study at sites across the country.

Principal Investigator: Mark Wyers, MD
Coordinator: Mary Trovato, RN, BSN

 

Additional Trials

Overlay in Hybrid OR with Vessel Navigator Study

Purpose : The primary objective of this evaluation is to formulate guidelines on when, why and how 3D intra-operative imaging tools should be used during endovascular procedures. The study will also examine the suitable application scope, ease of use and clinical benefit of the Vessel Navigator (an improvement to the existing Philips multimodality roadmapping tool that allows MR/CT overlay on live fluoroscopy) in vascular procedures. This is a single center study taking place at BIDMC and will enroll 150 patients.
More information

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