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
34
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
Universitätsklinikum Graz
Graz, Austria
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Baden-Wurttemberg, Germany
Amputation-free Survival
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
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 as Assessed by Duplex Ultrasound
Stent graft patency as assessed by duplex ultrasound and calculated using the Kaplan-Meier estimate
Time frame: Throughout one year
Limb Salvage
Freedom from major amputation as calculated using the Kaplan-Meier estimate
Time frame: Throughout one year
Deterioration in Renal Function
Number of participants with deterioration in renal functionas assessed by changes in creatinine level
Time frame: One month and six months
Interventions With 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
Time frame: Immediately post-procedure
Interventions With 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinikum Arnsberg GmbH
Arnsberg, North Rhine-Westphalia, Germany
St. Franziskus-Hospital GmbH
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Auckland City Hospital
Auckland, New Zealand
...and 2 more locations