Trials / Recruiting
RecruitingNCT05313165
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- LimFlow, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Detailed description
The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LimFlow Stent Graft System | Creation of an arteriovenous fistula in the desired limb location |
Timeline
- Start date
- 2022-12-22
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2022-04-06
- Last updated
- 2026-04-16
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05313165. Inclusion in this directory is not an endorsement.