Status:
COMPLETED
PROMISE International
Lead Sponsor:
LimFlow SA
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
21-95 years
Phase:
NA
Brief 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 wit...
Detailed 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 ap...
Eligibility Criteria
Inclusion
- 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
- 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 m²) 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)
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03321552
Start Date
December 15 2017
End Date
January 23 2025
Last Update
January 7 2026
Active Locations (12)
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1
Universitätsklinikum Graz
Graz, Austria, 8036
2
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Baden-Wurttemberg, Germany, 76307
4
Klinikum Arnsberg GmbH
Arnsberg, North Rhine-Westphalia, Germany, 59755