FRAME, External Support for Lower Limb Autologous Grafts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Peripheral Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FRAME

Vein graft to be treated with FRAME

Group Type EXPERIMENTAL

FRAME

Intervention Type DEVICE

External support for vein grafts in peripheral bypass surgery

Interventions

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FRAME

External support for vein grafts in peripheral bypass surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
2. Rutherford classification 3-6
3. 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.
4. Patient is able and willing to give their informed written consent.
5. Patient is able and willing to comply with study follow up requirements.
6. Patient is ≥ 18 years of age

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No