Status: No Longer Enrolling
Do you have poor blood flow associated with Critical Limb Ischemia?
If you have peripheral arterial disease (PAD) - also known as poor blood flow, and associated with Critical Limb Ischemia (CLI), this study may be an option for you.
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
Candidates for Critical Limb Ischemia Study
You may qualify for this study if you:
- Male or female, age 18 years or older.
- Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
- CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
- Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
- Adequate aortoiliac inflow.
- Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
- Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Study Length & Information: Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost-effectiveness outcomes after treatment.
Principal Investigator: Jeffrey M. Slaiby, MD, FACS, RPVI