PROMISE International
Study Details
Study Description
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 with critical limb ischemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Percutaneous deep vein arterialization Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach |
Procedure: Percutaneous deep vein arterialization
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Device: LimFlow System
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
Outcome Measures
Primary Outcome Measures
- Amputation-free survival [Throughout one year]
Freedom from death or major amputation
Secondary Outcome Measures
- Wound healing [Throughout one year]
Complete index wound healing as assessed by wound pictures
- Primary and secondary patency as assessed by duplex ultrasound [Throughout one year]
Stent graft patency as assessed by duplex ultrasound
- Limb salvage: Freedom from major amputation [Throughout one year]
Freedom from major amputation
- Deterioration in renal function as assessed by creatinine level [One month and six months]
Changes in creatinine level
- Technical success (procedure completion) [Immediately post-procedure]
Procedure completion and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft
- Procedural success (technical success without death, major amputation, or re-intervention) [One month post-procedure]
Combination of technical success without death, major amputation, or re-intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be > 21 and < 95 years of age
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Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
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Assessment that no conventional surgical or endovascular treatment is possible
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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
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Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits
Exclusion Criteria:
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Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
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Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
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Life expectancy less than 12 months
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Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
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Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
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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
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Patient unable to give consent
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Pregnant or breastfeeding women
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Documented myocardial infarction or stroke within previous 90 days
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Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
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Patients with vasculitis and/or untreated popliteal aneurysms
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Patients with acute limb ischemia
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Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
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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
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Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
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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
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Graz | Graz | Austria | 8036 | |
| 2 | Universitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg | Germany | 69120 |
| 3 | SRH Klinikum Karlsbad-Langensteinbach | Karlsbad | Baden-Württemberg | Germany | 76307 |
| 4 | Klinikum Arnsberg GmbH | Arnsberg | North Rhine-Westphalia | Germany | 59755 |
| 5 | St. Franziskus-Hospital GmbH | Münster | North Rhine-Westphalia | Germany | 48145 |
| 6 | Universitätsklinikum Leipzig | Leipzig | Saxony | Germany | 4103 |
| 7 | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | 5200 ME | |
| 8 | Noordwest Ziekenhuisgroep | Alkmaar | Netherlands | 1815 JD | |
| 9 | St. Antonius Hospital | Nieuwegein | Netherlands | 3430 EM | |
| 10 | Auckland City Hospital | Auckland | New Zealand | ||
| 11 | Tan Tock Seng Hospital | Singapore | Singapore | 308433 | |
| 12 | Changi General Hospital | Singapore | Singapore | 529889 |
Sponsors and Collaborators
- LimFlow SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- EU PMS Revision 4.1