Clinical trial NCT06315023: The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
Official title: Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Symptomatic Femoropopliteal Lesions
Lead sponsor: Endologix
Sponsor class: INDUSTRY
Collaborators: name: Fivos
name: Massachusetts General Hospital
name: Society for Vascular Surgery Patient Safety Organization
First posted: 2024-03-18
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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.

Eligibility criteria: 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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Primary outcomes:
measure: Freedom from CD-TLR
timeFrame: 1 Year
measure: Freedom from MAE
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Salinas Valley Memorial Hospital
state: California
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: West Chester
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health
state: Pennsylvania
Study officials:
References: