MedTrace Logo

Pivotal Trial of the Boomerang Catheter for pDVA

NCT06311773 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-20

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.

Conditions

  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

Boomerang Catheter

The study device used for this procedure makes an anastomosis between a tibial vein and a tibial artery to direct blood flow around blocked arteries.

Sponsors & Collaborators

  • Aveera Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2027-03-31
Completion
2030-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311773 on ClinicalTrials.gov