Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
LimFlow, Inc.
Summary
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
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.
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject must be ≥ 18 and ≤ 95 years of age 2. Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 \< 30 mm Hg) and 1. Rutherford Classification 5, ischemic ulceration or 2. Rutherford Classification 6, ischemic gangrene 3. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage…
Interventions
- DeviceLimFlow Stent Graft System
Creation of an arteriovenous fistula in the desired limb location
Locations (30)
- University of California, San Diego HealthLa Jolla, California
- Stanford University School of MedicinePalo Alto, California
- UCSFSan Francisco, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, California
- Yale UniversityNew Haven, Connecticut
- The Cardiac and Vascular InstituteGainesville, Florida