Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Summary

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Conditions

• Critical Limb Ischemia

Interventions

PROCEDURE

Open surgical revascularization

DEVICE

Endovascular revascularization

A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Boston Medical Center

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Abbott

  collaborator INDUSTRY

• Bard Ltd

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Cordis Corporation

  collaborator INDUSTRY

• Abbott Medical Devices

  collaborator INDUSTRY

• Canadian Society for Vascular Surgery

  collaborator UNKNOWN

• Eastern Vascular Society

  collaborator UNKNOWN

• W.L.Gore & Associates

  collaborator INDUSTRY

• Midwest Vascular Society

  collaborator UNKNOWN

• New England Society for Vascular Surgery

  collaborator UNKNOWN

• Society for Clinical Vascular Surgery

  collaborator UNKNOWN

• Society for Interventional Radiology

  collaborator UNKNOWN

• Southern Vascular Society

  collaborator UNKNOWN

• Society for Vascular Medicine

  collaborator UNKNOWN

• Society for Vascular Surgery

  collaborator OTHER

• Vascular and Endovascular Surgery Society

  collaborator UNKNOWN

• Vascular Interventional Advances

  collaborator UNKNOWN

• Western Vascular Society

  collaborator UNKNOWN

• Carelon Research

  lead OTHER

Principal Investigators

• Matthew Menard, MD · Brigham and Women's Hospital

• Alik Farber, MD · Boston University

• Kenneth Rosenfield, MD · Massachusetts General Hospital

• Mark Cziraky, PharmD, CLS · Carelon Research

• Taye Hamza, PhD · Carelon Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2022-03-01

Completion

2022-03-01

FDA Device

Yes

Countries

• United States
• Canada
• Finland
• Italy
• New Zealand

Study Locations