The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
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| 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). |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Endologix
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.