Deep Vein Arterialization for Amputation Prevention in PAD Patients

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.

In order to participate you must meet the following criteria:

• Have a clinical diagnosis of chronic limb-threatening ischemia, Rutherford Classification 5, 6, ischemic gangrene.
• Have 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 of the following:
  • Absence of a usable pedal artery target (endovascular or surgical approach).
  • 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.
• Are enrolled in an acceptable wound care network and have an adequate support network to compliance with medication regimen and follow-up study visits.
• Have stable glycemic control, HbA1C < 10% (<269mg/dL).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.