PROMISE III
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StatusAccepting Candidates
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Age18 Years - 95 Years
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SexesAll
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Healthy VolunteersNo
Objective
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.
Details
Full study title | Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia |
Protocol number | OCR42230 |
ClinicalTrials.gov ID | NCT05313165 |
Phase | N/A |
Eligibility
Inclusion 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., 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.
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% ( 6 months
Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
Serum albumin > 30 g/liter
BMI > 20
Exclusion Criteria:
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.
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 compromise subject's safety).
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, hyperpigmentation, or medial ulceration
above the ankle).
- Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in
subjects 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.
Lead researcher
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Vascular Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Benjamin Jacobs -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.