The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
PTAB1
Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
1 other identifier
observational
450
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2023
CompletedFirst Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 7, 2032
May 11, 2025
May 1, 2025
4.7 years
March 11, 2024
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom from CD-TLR
Primary Effectiveness outcome is patency as defined as Freedom from Clinical Driven Target Lesion Revascularization (CD-TLR)
1 Year
Freedom from MAE
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.
30 Days
Study Arms (2)
As Treated
All patients that have received the therapy; patients treated within and outside the IFU criteria subgroups; male and female subgroups; and duplex imaging subgroups for arterial and venous observations.
Imaging Cohort
Sites that are performing (arterial and venous) duplex ultrasound assessments according to the institution's standard practice will be asked to participate in the DUS imaging cohort. The Imaging sub-study will consist of 55 female and 55 male subjects from these sites. Duplex imaging at 1-, 12-, 24-, and 36-months post-procedure will be collected to assess the endpoints of graft patency and venous thrombus within the vein containing the graft (n=110).
Interventions
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endologixlead
- Fivoscollaborator
- Massachusetts General Hospitalcollaborator
- Society for Vascular Surgery Patient Safety Organizationcollaborator
Study Sites (10)
Salinas Valley Memorial Hospital
Salinas, California, 93901, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
University of Pennsylvania
West Chester, Pennsylvania, 19380, United States
Main Line Health
Wynnewood, Pennsylvania, 19096, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 60 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
October 6, 2023
Primary Completion (Estimated)
June 7, 2028
Study Completion (Estimated)
June 7, 2032
Last Updated
May 11, 2025
Record last verified: 2025-05