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.
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
Coordinator: Jorge Gomez-Mayorga
Project Manager: Diana Cepeda
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
Coordinator: Jorge Gomez-Mayorga
Secondary Coordinator: Diana Cepeda
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
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
Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients with Significant Carotid Artery Disease. The ROADSTER 3 Study
Purpose: Open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for carotid endarterectomy who require carotid revascularization and who are eligible for treatment with a combination of the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.
Principal Investigator and National PI: Marc Schermerhorn, MD
Coordinator: Jorge Gomez-Mayorga
Secondary Coordinator: Diana Cepeda
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 Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI)
Purpose: This is a prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI) 376 subjects will be randomized to treatment with either the SELUTION SLR DEB or a commercially available uncoated balloon (PTA) Subjects will be followed through 5 years with follow-up clinical visits at 1, 6, 12, 24, and 36 months (total of 5 in person visit post procedure), and telephone follow-up visits at 48 and 60 months.
Principal Investigator: Mark Wyers MD
Coordinator: Jorge Gomez-Mayorga
Secondary Coordinator: Diana Cepeda
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients with Complex Iliac Occlusive Disease.
Purpose: This study is a prospective, multicenter, randomized-controlled clinical trial to demonstrate the superiority of the VBX Stent Graft for when compared to bare metal stenting in complex iliac occlusive disease. 244 subjects will be enrolled at 40 sites. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24-, 36-, 48-, and 60-months post-treatment for a total of 6 post randomization visits. Subjects will participate for 5 years.
Principal Investigator: Mark Wyers MD
Coordinator: Jorge Gomez-Mayorga
Secondary Coordinator: Diana Cepeda