RecruitingNot Applicable

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

United States100 participantsStarted 2022-12-22

Plain-language summary

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Age range18 Years – 95 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
✓. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
✓. Subject is willing and able to sign the informed consent form.
✓. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.

✕. 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.
✕. Life expectancy less than 12 months.
✕. Documented myocardial infarction or stroke within previous 90 days.
✕. Active infection (e.g., fever, significantly elevated WBC count \>20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).
✕. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.

Amputation Free Survival

Timeframe: 6 Months

NCT IDNCT05313165

SponsorLimFlow, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-01

Erin Towery

Who can participate

Age range18 Years – 95 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
✓. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
✓. Subject is willing and able to sign the informed consent form.
✓. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.

✕. 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.
✕. Life expectancy less than 12 months.
✕. Documented myocardial infarction or stroke within previous 90 days.
✕. Active infection (e.g., fever, significantly elevated WBC count \>20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).
✕. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.