FRAME, External Support for Lower Limb Autologous Grafts

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

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.

Study Overview

• Status: Suspended
• Conditions: Peripheral Arterial Disease; Peripheral Artery Disease
• Intervention / Treatment: Device: FRAME

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital of Indiana
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FRAME; Vein graft to be treated with FRAME	Device: FRAME; External support for vein grafts in peripheral bypass surgery

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

Collaborators and Investigators

• Sponsor: Vascular Graft Solutions Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PAD; Saphenous vein graft; Peripheral bypass surgery; external support
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CD0177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes