Peripheral Arterial DiseasePTAB1NCT06315023
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
An observational study of Peripheral Arterial Disease and Symptomatic Femoropopliteal Lesions, run by Endologix at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions
- What is being tested?
- DETOUR System
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Oct 2023to 7 Jun 2032
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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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Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Delray Medical Center
Delray Beach, Florida, 33484
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
NYU Langone Medical Center
New York, New York, 10016
Salinas Valley Memorial Hospital
Salinas, California, 93901
University of Connecticut
Storrs, Connecticut, 06269
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Pennsylvania
West Chester, Pennsylvania, 19380
Main Line Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
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.
Read the 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.
- Being tested
- DETOUR System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETOUR SystemDevice
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DETOUR System | |
| 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). Receives: Device: DETOUR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from CD-TLR
Primary Effectiveness outcome is patency as defined as Freedom from Clinical Driven Target Lesion Revascularization (CD-TLR)
Measured: 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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start6 Oct 2023
- Primary completion7 Jun 2028 (estimated)
- Study completion7 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fivos, Massachusetts General Hospital, Society for Vascular Surgery Patient Safety Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315023
- Sponsor's protocol ID
- CP-0029
- Acronym
- PTAB1
- Status last verified
- May 2026
- First submitted
- 11 Mar 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
- ClinicalTrials.gov ID
- NCT06315023
- Acronym / sponsor ID
- PTAB1 / CP-0029
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Collaborators
- Fivos, Massachusetts General Hospital, Society for Vascular Surgery Patient Safety Organization
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 7 Jun 2028 (estimated)
- Study completion
- 7 Jun 2032 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| As Treated | – | Device: DETOUR SystemAll 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 | – | Device: DETOUR SystemSites 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DETOUR SystemPercutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System | Device | As Treated, Imaging Cohort |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Symptomatic Femoropopliteal Lesions, run by Endologix at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from CD-TLR (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.