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A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Full 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.
Enrollment
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Volunteers
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
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% (<269mg/dL)
Subjects requiring dialysis may be included, provided they meet all the following requirements:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Erin Towery
Data sourced from clinicaltrials.gov
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