FRAME, External Support for Lower Limb Autologous Grafts

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Conditions studied: Peripheral Arterial Disease, Peripheral Artery Disease

In brief

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.

Key facts

Study ID: NCT04003480
Run by: Vascular Graft Solutions Ltd.
People needed: 30
Starts: 2026-12-31
Expected to finish: 2029-12-01
Last updated by the study team: 2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Patients indicated for endovascular treatment
Prior surgical bypass procedure in ipsilateral lower limb.
Active ulcer/infection/gangrene at the intended distal anastomosis site.
Severe vein varicosity
Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
Spliced vein technique
In-situ vein technique
Pedal/plantar distal anastomosis
Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
Patients with history of hypercoagulable conditions.
Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
Contraindication to recommended study medications
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Where it is running

Lutheran Hospital of Indiana — Fort Wayne, Indiana, United States
University of Maryland Baltimore — Baltimore, Maryland, United States
Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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