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The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

NCT06315023 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-05-12

No results posted yet for this study

Summary

The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

Conditions

  • Peripheral Arterial Disease
  • Symptomatic Femoropopliteal Lesions

Interventions

DEVICE

DETOUR System

Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System

Sponsors & Collaborators

  • Fivos

    collaborator UNKNOWN

  • Massachusetts General Hospital

    collaborator OTHER

  • Society for Vascular Surgery Patient Safety Organization

    collaborator OTHER

  • Endologix

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2028-06-07
Completion
2032-06-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT06315023 on ClinicalTrials.gov