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New treatment option for Critical Limb Ischemia
Official title PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
ClinicalTrials.gov ID: NCT05313165
What this study is testing
- What it's testing
- A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 95
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
- Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
- Stable glycemic control, HbA1C \< 10% (\<269mg/dL)
- people requiring dialysis may be included, provided they meet all the following requirements:
- On dialysis for \> 6 months
- Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
- Serum albumin \> 30 g/liter
- BMI \> 20
- 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...
- Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
- Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may...
- Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein...
- Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in people not undergoing dialysis.
- Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.
- Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Tallahassee, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- Pomona, New Jersey, United States
- Teaneck, New Jersey, United States
- Albuquerque, New Mexico, United States
- Lake Success, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Hershey, Pennsylvania, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Torrance, California, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.