FRAME, External Support for Lower Limb Autologous Grafts

Study Overview
=================
Brief 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.

Official Title
-----------------
Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.

Conditions
-----------------
Peripheral Arterial Disease, Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: FRAME


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FRAME<br>Vein graft to be treated with FRAME | Device: FRAME<br>* External support for vein grafts in peripheral bypass surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saphenous vein graft, PAD, Peripheral bypass surgery, external support