PROMISE International

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    LimFlow SA
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Updated on 26 February 2022
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ischemia
limb ischemia

Summary

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Description

This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Details
Condition Critical Limb Ischemia
Treatment Percutaneous deep vein arterialization, LimFlow System
Clinical Study IdentifierNCT03321552
SponsorLimFlow SA
Last Modified on26 February 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject must be > 21 and < 95 years of age
Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
Assessment that no conventional surgical or endovascular treatment is possible
Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be <50% stenosed
Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Exclusion Criteria

Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
Life expectancy less than 12 months
Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
Patient 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 treatment
Patient unable to give consent
Pregnant or breastfeeding women
Documented myocardial infarction or stroke within previous 90 days
Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m) who are not on hemodialysis
Patients with vasculitis and/or untreated popliteal aneurysms
Patients with acute limb ischemia
Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of < 40%, NYHA Classification III-IV)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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