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New bypass device tested in Real-World leg artery study

NCT ID NCT06315023

Disease control Sponsor: Endologix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is following 450 people with long blockages in their leg arteries who are treated with the DETOUR System, a device that creates a bypass inside the artery. The goal is to see how well it works and how safe it is in everyday medical practice. Participants are chosen by their doctor based on standard guidelines, and the study will track whether the artery stays open and if any major problems occur within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DETOUR System (a device that creates a bypass inside the leg artery)
What this could lead to
If successful, this could confirm that the DETOUR System is a safe and effective option for people with long blockages in leg arteries who cannot have standard surgery or stenting.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less conclusive. Risks include artery damage, infection, or the bypass failing over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. \-

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease Symptomatic femoropopliteal lesions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Main Line Health

    Wynnewood, Pennsylvania, 19096, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Salinas Valley Memorial Hospital

    Salinas, California, 93901, United States

  • University of Connecticut

    Storrs, Connecticut, 06269, United States

  • University of Pennsylvania

    West Chester, Pennsylvania, 19380, United States

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