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Boomerang-Pivotal Multicenter Trial of the Boomerang Catheter for Percutaneous Deep Vein Arterialization (pDVA)

Clinical Trial Details

The purpose of the trial is to find out if an investigational device called the “Boomerang Catheter System,” containing Boomerang Catheter and Boomerang Power Controller works for a new use in the leg and to monitor the safety in treating blockages in the arteries located behind and below the knee down to the small arteries located at the joint of the leg and foot in patients suffering from low blood flow to the lower leg.

This device has not been approved by U.S. Food and Drug Administration (FDA). A similar version of this device was cleared by FDA in 2018 for use in the arm to create an artery – vein connection (fistula) for patients needing dialysis.

Participants will be assessed by a study physician and an Independent Review Committee (IRC) to determine study eligibility.

The duration of the study is up to 4 ½ years with follow-up visits at: 1 week, 1 month, 2 months, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with Chronic Limb Ischemia (CLTI) of Rutherford Category 5 or 6.
  2. Participant must have a no option for conventional distal bypass, surgical or endovascular therapy for limb salvage

   * Diabetic patients must have adequate glycemic control *

General Exclusion:

  1. Patient is dialysis dependent
  2. Prior Peripheral arterial bypass procedure on limb within 30 days

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rosa Aurora Chu
roc2025@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2407027708

ClinicalTrials.gov:

NCT06311773

Sponsor:

24-01

Status

Open to Enrollment

Age Group

Adult

Sponsor