Trials / Enrolling By Invitation
Enrolling By InvitationNCT06311773
Pivotal Trial of the Boomerang Catheter for pDVA
Pivotal Multicenter Trial of the Boomerang® Catheter for Percutaneous Deep Vein Arterialization (pDVA)
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Aveera Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-04-16
- Primary completion
- 2027-03-31
- Completion
- 2030-03-31
- First posted
- 2024-03-15
- Last updated
- 2026-02-20
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06311773. Inclusion in this directory is not an endorsement.