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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
North Bristol NHS Trust
Bristol, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Amputation-free Survival
Freedom from death or major amputation
Time frame: Throughout one year
Wound Healing
Complete index wound healing as assessed by wound pictures
Time frame: Throughout one year
Primary and Secondary Patency
Stent graft primary and secondary patency as assessed by duplex ultrasound
Time frame: Throughout one year
Limb Salvage
Freedom from major amputation
Time frame: Throughout one year
Technical Success (Procedure Completion)
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, as assessed angiographically
Time frame: Immediately post-procedure (approximately 4 hours after vascular access)
Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)
Combination of technical success without death, major amputation, or re-intervention
Time frame: One month post-procedure
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St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom