FRAME, External Support for Lower Limb Autologous Grafts (NCT04003480) | Clinical Trial Compass
SuspendedNot Applicable
FRAME, External Support for Lower Limb Autologous Grafts
Stopped: no patients have been enrolled. Study suspended due to change of sponsor priorities during COVID
United States30 participantsStarted 2026-12-31
Plain-language summary
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.
Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
✓. Rutherford classification 3-6
✓. Adequate 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.
✓. Patient is able and willing to give their informed written consent.
✓. Patient is able and willing to comply with study follow up requirements.
✓. Patient is ≥ 18 years of age
Exclusion criteria
✕. Patients indicated for endovascular treatment
✕. Prior surgical bypass procedure in ipsilateral lower limb.
✕. Active ulcer/infection/gangrene at the intended distal anastomosis site.