PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorLimFlow, Inc.
About this trial
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Eligibility criteria
Qualifiers
Subject must be ≥ 18 and ≤ 95 years of age
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
Rutherford Classification 5, ischemic ulceration or
Rutherford Classification 6, ischemic gangrene
Disqualifiers
Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
Absence of adequate viable tissue in target foot.
Trial design
Treatments tested in this trial
- LimFlow Stent Graft System
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
30California
University of California, San Diego Health92093, La Jolla United States
Stanford University School of Medicine94304, Palo Alto United States
UCSF94143, San Francisco United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center90502, Torrance United States
Sponsors and collaborators
LimFlow, Inc.
Lead sponsor
Source ClinicalTrials.gov