Interventional Peripheral Vascular Disease Research

CREST-2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Summary: Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

• Primary Investigator: Scott Silverman, MD*
• Study Population or Disease Focus: Patients with asymptomatic high-grade carotid stenosis
• Status: Enrolling
• Source: Industry-initiated

*While Dr. Silverman is a physician within the Mass General Department of Neurology, multiple Mass General interventional cardiologists take part in the carotid stenting (CAS) arm of the trial.

The RADIANCE-HTN Clinical Study: A Study of the ReCor Medical PARADISE® System in Clinical Hypertension

Summary: The objective of the RADIANCE-HTN study is to test the efficacy of the Paradise renal denervation system as a means to decrease the resting blood pressure in hypertensive patients.

• Primary Investigator: Joseph Garasic, MD
• Study Population or Disease Focus: Adults with history of hypertension
• Status: Follow-up only
• Source: Industry-initiated

The RADIANCE II Pivotal Study: A Study of the ReCor Medical PARADISE® System in Stage II Hypertension

Summary: The objective of the RADIANCE II study is to test the effectiveness and safety of the Paradise renal denervation system as a means to decrease the resting blood pressure in patients with stage 2 hypertension on 0-2 medications.

• Primary Investigator: Joseph Garasic, MD
• Study Population or Disease Focus: Patients with a history of Hypertension who may currently take hypertension medications
• Status: Enrolling
• Source: Industry-initiated

TARGET BP I: Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension

Summary: This trial compares renal denervation performed with the Peregrine System Kit to a control group receiving no renal denervation in order to determine the safety and effectiveness of the Peregrine Catheter on relieving hypertension in patients who are adequately managed with oral antihypertensive medications.

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: Patients on medication for hypertension
• Status: Enrolling
• Source: Industry-initiated

C2R: The CREST-2 Registry

Summary: TThe objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists.

• Mass Genreal IC Collaborators: Joseph Garasic, MD, Ken Rosenfield, MD, Rahul Sakhuja, MD
• Study Population or Disease Focus: Patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease
• Status: Enrolling
• Source: PI-initiated

CTEPH-BPA Registry: A retrospective study of adults who have CTEPH and underwent a balloon pulmonary angioplasty (BPA)

Summary: This is a registry to gather data on patients who undergo balloon pulmonary angioplasty (BPA) procedures at Mass General.

• Primary Investigator: Ken Rosenfield, MD
• Study Population or Disease Focus: Patients with CTEPH undergoing BPAs at Mass General
• Status: Enrolling
• Source: PI-initiated

IVUS/PAD: Impact of Intravascular Ultrasound on Decision-Making in Lower Extremity Revascularization

Summary: This study is to evaluate how a special imaging catheter known as intravascular ultrasound (IVUS) may help guide procedures to open blocked or narrowed leg arteries in patients with peripheral artery disease (PAD).

• Primary Investigator: Ken Rosenfield, MD
• Study Population or Disease Focus: Adults with peripheral artery disease undergoing revascularization
• Status: Start-up
• Source: PI-initiated

Metabolomic and Circulating MicroRNA Profile of Lower Extremity Revascularization in Peripheral Artery Disease

Summary: This research to understand how opening blocked arteries (also known as revascularization) in the leg of people with peripheral artery disease (PAD) affects the muscles of these patients. We hope to better understand how revascularization improves symptoms and quality of life in people with PAD. People with PAD may or may not have an improvement in the severity of their symptoms with revascularization. However, it is not clear how revascularization exerts its beneficial effects, and we currently do not have a clear understanding of the effect of revascularization on the muscles of patients with PAD. We ultimately hope to develop new tools for predicting whether patients with PAD will improve with revascularization.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Adults with peripheral artery disease and lower extremity ischemia at rest and/or with exercise)
• Status: Closed to enrollment
• Source: PI-initiated