SHS_300274 BERR FNEW/FNIH 14095

SHS 300274 BERR FNEW/FNIH 14095-Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

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. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

Inclusion Criteria:
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.

Exclusion Criteria:
Presence of a popliteal aneurysm (>2 cm) in the index limb.
Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).
Any of the following procedures performed on the index limb within 3 months prior to enrollment: Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft; Infrainguinal bypass with either venous or prosthetic conduit
Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
Current chemotherapy or radiation therapy.
Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.
Heart and Vascular
Swee Lian Tan, M.D.
New England Research Institutes/National Heart, Lung, and Blood Institute
Jennifer Nagel
  • Swedish Medical Center