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OpenTrials
Enrolling by Invitation

NCT Number: NCT06315023

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

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.

Enrolling by Invitation

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Symptomatic Femoropopliteal Lesions Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Salinas Valley Memorial Hospital, Salinas, California, United States

Loading trial locations.

About this study

A maximum of 450 subjects will be enrolled with a target study population of at least 200 evaluable female and 200 evaluable male participants at the 12-month post-procedure follow-up visit. A maximum of 200 US sites. Sites will be selected that participate or will participate in the VQI PVI Registry. Follow up visits/assessments will be completed at 1, 12, 24-, 36-, 48-, and 60-months post-procedure. Study enrollment is expected to conclude over 4 years. Follow up data at 1 year is expected to conclude in 5 years from enrollment, with 5-year follow up expected to conclude in 9 years from enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use.

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Exclusion criteria

There are no exclusion criteria. All cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan.

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Treatment and study plan

DETOUR System

Device

Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System

Primary outcomes

  1. Freedom from CD-TLR

    Time frame: 1 Year

    Primary Effectiveness outcome is patency as defined as Freedom from Clinical Driven Target Lesion Revascularization (CD-TLR)

  2. Freedom from MAE

    Time frame: 30 Days

    Primary Safety outcome is freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), and/or Major Amputation of the Treated Limb.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Collaborators

  • Fivos
  • Massachusetts General Hospital
  • Society for Vascular Surgery Patient Safety Organization

Registry information

Official study title

Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients

Acronym: PTAB1

Important dates

Study start
2023
Primary completion
2028
Study completion
2032
First posted
Mar 18, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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