FRAME, External Support for Lower Limb Autologous Grafts

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04003480
• Other study ID #: CD0177
• Status: Suspended
• Phase: N/A
• Start date: December 31, 2026
• Est. completion date: December 2029

Study information

• Verified date: April 2023
• Source: Vascular Graft Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases

Intervention

Device:
• FRAME
External support for vein grafts in peripheral bypass surgery

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	Lutheran Hospital of Indiana	Fort Wayne	Indiana
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Graft Solutions Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound	12 months