NCT04003480

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.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vascular Graft Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	FRAME	External support for vein grafts in peripheral bypass surgery

Timeline

• Start date: 2026-12-31
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2019-07-01
• Last updated: 2025-02-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study