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NCT06315023 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— PTAB1  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06315023
Other study ID # CP-0029
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 6, 2023
Est. completion date June 7, 2032

Study information
Verified date March 2024
Source Endologix
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 450
Est. completion date June 7, 2032
Est. primary completion date June 7, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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. - 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. -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System

Locations
Country Name City State
United States NYU Langone Medical Center New York New York

Sponsors (4)
Lead Sponsor Collaborator
Endologix Fivos, Massachusetts General Hospital, Society for Vascular Surgery Patient Safety Organization

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom from CD-TLR Primary Effectiveness outcome is patency as defined as Freedom from Clinical Driven Target Lesion Revascularization (CD-TLR) 1 Year
Primary 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
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