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FRAME, External Support for Lower Limb Autologous Grafts

NCT04003480 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-04

No results posted yet for this study

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

Interventions

DEVICE

FRAME

External support for vein grafts in peripheral bypass surgery

Sponsors & Collaborators

  • Vascular Graft Solutions Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003480 on ClinicalTrials.gov