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Peripheral Arterial DiseaseNCT03119233

The DETOUR 2 Clinical Trial

A study testing DETOUR System in people with Peripheral Arterial Disease, run by Endologix at 34 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
DETOUR System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
34 sitesin 3 countries
Study dates
13 Dec 2017to 13 Nov 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study:
  • General Inclusion Criteria
  • Age > 18 and ≤ 90 years of age.
  • Willing and able to provide informed consent.
  • Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
  • Clinical Inclusion Criteria
Show all 39Show fewer
  • Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.
  • Venous Clinical Severity Score < 3.
  • Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
  • Angiographic Inclusion Criteria
  • Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment.
  • Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment.
  • Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone
  • Able to successfully access the SFA origin for entry of the crossing device.
  • At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot.
  • A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
  • General Exclusion Criteria
  • Participating in another investigational clinical study.
  • Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial.
  • Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  • Clinical Exclusion Criteria
  • History of deep vein thrombosis on either limb.
  • Thrombophlebitis, within the previous 30 days.
  • 6. Planned major amputation of the target limb, including minor amputation (above the ankle).
  • Prior distal amputation (above the transmetatarsal) of the target limb.
  • Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS])
  • Rutherford clinical category 0, 1, 2 or 6.
  • Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.
  • Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
  • Morbid obesity that does not allow for safe vascular access or imaging.
  • Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8.
  • Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.
  • Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.
  • Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria
  • Stent within 3 cm of SFA ostium.
  • Previous bypass surgery on the target limb.
  • Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication)
  • Presence of aneurysm or acute thrombus in the target limb.
  • Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Who cannot join

None listed.

Trial locations and contacts

34 sites in 3 countries.

34 sites in 3 countries

United States30 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • McLaren Bay Region Hospital

    Bay City, Michigan, 48708

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Bay Area Vein and Vascular

    Burlingame, California, 94010

  • Christie Clinic

    Champaign, Illinois, 61822

  • The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education

    Cincinnati, Ohio, 45219

  • Cleveland Clinical Foundation

    Cleveland, Ohio, 44195

  • North Dallas Research Associates

    Dallas, Texas, 75069

  • The Vascular Experts

    Darien, Connecticut, 06820

  • Denver VA Medical Center

    Denver, Colorado, 80220

  • AMITA Health Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Advanced Cardiac and Vascular Amputation Prevention Centers

    Grandville, Michigan, 49418

  • Greenville Health System

    Greenville, South Carolina, 29615

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Texas Tech

    Lubbock, Texas, 79409

  • Baptist Hospital Miami

    Miami, Florida, 33176

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53233

  • Community Hospital of the Monterrey Peninsula

    Monterey, California, 93940

  • Advanced Cardiovascular Specialists

    Mountain View, California, 94040

  • New York-Presbyterian / Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Cardiac & Vascular Research Center of Nothern Michigan

    Petoskey, Michigan, 49770

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • North Caroline Hearth and Vascular- University of North Carolina Rex

    Raleigh, North Carolina, 27607

  • HonorHealth

    Scottsdale, Arizona, 85251

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

Other trials in United States

Germany3 sites

  • Klinikum Hochsauerland GmbH

    Arnsberg, 59759

  • Cardioangiologisches Centrum Bethanien

    Frankfurt

  • Universität Leipzig

    Leipzig, 04203

Other trials in Germany

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

Other trials in Latvia

About this study

Official title: The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial

Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Read the detailed description

The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system.

The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.

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

    The DETOUR System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).

Study groups in NCT03119233
Study groupRoleWhat they receive
Single-ArmExperimentalThis is a prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the DETOUR System, delivery guidewires, and implant stent grafts for percutaneous femoropoliteal bypass compared to Performance Goals (PG)
Receives: Device: DETOUR System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Patency

    Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment.

    Measured: 12 months

  2. Major Adverse Events at 30 Days

    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), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery).

    Measured: 30 days

Secondary outcomes (3)

  1. Stent Graft Separation and Migration

    Stent graft separation and migration identified via ultrasound imaging

    Measured: 30 Days

  2. Stent Graft Separation and Migration Via 12-Month X-Ray

    Stent graft separation and migration identified via X-ray

    Measured: 12 Months

  3. Stent Graft Fracture Via 12-Month X-Ray

    Stent graft fracture identified via X-ray

    Measured: 12-Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start13 Dec 2017
  3. Primary completion22 Dec 2021
  4. Study completion13 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119233
Sponsor's protocol ID
STP 203
Status last verified
Mar 2025
First submitted
11 Apr 2017
Last updated
2 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Lyden SP, Soukas PA, De A, Tedder B, Bowman J, Mustapha JA, Armstrong EJ; DETOUR2 Trial Investigators. DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease. J Vasc Surg. 2024 Jun;79(6):1420-1427.e2. doi: 10.1016/j.jvs.2024.02.004. Epub 2024 Feb 15.

    PubMed 38367850

Questions about this trial

What is this clinical trial studying?

A study testing DETOUR System in people with Peripheral Arterial Disease, run by Endologix at 34 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Germany, Latvia. 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?

Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Patency (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT03119233, which also lists 1 linked publication.

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 2 Apr 2025.

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