NCT03321552CompletedNot Applicable
Percutaneous Deep Vein Arterialization Post-Market Study
LimFlow SA22 sites in 5 countries34 target enrollmentStarted: December 15, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 22
- Primary Endpoint
- Amputation-free Survival
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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)
Arms & Interventions
Percutaneous deep vein arterialization
Experimental
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Intervention: Percutaneous deep vein arterialization (Procedure)
Percutaneous deep vein arterialization
Experimental
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Intervention: LimFlow System (Device)
Outcomes
Primary Outcomes
Amputation-free Survival
Time Frame: Throughout one year
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
Secondary Outcomes
- Wound Healing(Throughout one year)
- Primary and Secondary Patency as Assessed by Duplex Ultrasound(Throughout one year)
- Limb Salvage(Throughout one year)
- Deterioration in Renal Function(One month and six months)
- Interventions With Technical Success (Procedure Completion)(Immediately post-procedure)
- Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)(One month post-procedure)
Investigators
Study Sites (22)
Loading locations...
Similar Trials
Completed
Not Applicable
Percutaneous Deep Vein Arterialization Post-Market StudyCritical Limb IschemiaNCT03807661LimFlow SA28
Terminated
Not Applicable
Evaluation of FUSION™ Vascular Graft for Above Knee TargetsPeripheral Arterial Occlusive Disease (PAOD)NCT01601496Maquet Cardiovascular117
Recruiting
Not Applicable
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening IschemiaCritical Limb IschemiaChronic Limb-Threatening IschemiaPeripheral Arterial DiseaseNCT05313165LimFlow, Inc.100
Recruiting
Not Applicable
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening IschemiaCritical Limb-Threatening IschemiaPeripheral Arterial DiseaseDiabetic FootNCT06277362EndoCore Lab s.r.l.50
Active, not recruiting
Not Applicable
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening IschemiaCritical Limb IschemiaCritical Lower Limb IschemiaPeripheral Artery DiseaseArterial DiseaseChronic Limb-Threatening IschemiaArterial Occlusive DiseasesArterial OcclusionPeripheral Artery OcclusionPeripheral IschemiaVascular DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseaseNCT03970538LimFlow, Inc.105