Explore This Research Program

Overview

The peripheral vascular system consists of the network of arteries and veins that carry blood throughout the body. Cholesterol plaques, blood clots and inflammation can injury and create blockages within the peripheral vascular system. Depending on the location of the blockages, symptoms can range from arm and leg pain, dizziness or even high blood pressure. The innovative research being conducted at Massachusetts General Hospital seeks to improve the clinical diagnosis and management of patients living with peripheral vascular disease. Specifically, our Mass General investigators are investigating techniques to ablate nerves within arteries supplying the kidneys in order to treat high blood pressure. Additionally, researchers at Mass General are studying innovative catheter-based techniques to treat blood clots in the lung arteries.

Peripheral Artery Disease Clinical Trials

Clinical Research Trials

CREST-2

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.
RADIANCE-HTN

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
RADIANCE II

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

Registries and Other Research

C2R

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.

CTEPH-BPA Registry

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

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
KNOCOUT PE

KNOCOUT PE: Retrospective and prospective international EKoSoNic® registry Of the treatment and Clinical OUTcomes of patients with Pulmonary Embolism

Summary: The purpose of this registry is to understand how doctors are currently treating pulmonary embolism (clot) with clot dissolving drugs and the EkoSonic® Endovascular System, the device decided by your doctor outside of this research study to treat your pulmonary embolism (clot).

  • Primary Investigator: Ken Rosenfield, MD
  • Study Population or Disease Focus: Adults being treated for pulmonary embolism with the EKOS device
  • Status: Follow-up only
  • Source: Industry-initiated
Metabolomic and Circulating MicroRNA Profile of Lower Extremity Revascularization in Peripheral Artery Disease

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: Enrolling
  • Source: PI-initiated