FRAME, External Support for Lower Limb Autologous Grafts

NCT04003480 | Suspended DMC FDA Device

• 1 other identifier: CD0177
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease

Keywords

Saphenous vein graft; PAD; Peripheral bypass surgery; external support

Outcome Measures

Primary Outcomes (1)

• Primary patency

  Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound

  12 months

Study Arms (1)

FRAME

EXPERIMENTAL

Vein graft to be treated with FRAME

Device: FRAME

Interventions

FRAME DEVICE

External support for vein grafts in peripheral bypass surgery

FRAME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vascular Graft Solutions Ltd.: lead

Study Sites (3)

Lutheran Hospital of Indiana

Fort Wayne, Indiana, 46804, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)