Peripheral Arterial DiseaseDETOUR1NCT02471638
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
A study testing PQ Bypass System for Femoropopliteal Bypass in people with Peripheral Arterial Disease, run by Endologix at 8 sites in 6 countries.
Trial summary
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous 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?
- PQ Bypass System for Femoropopliteal Bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jan 2015to Jun 2020
- 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
- Willing and able to provide informed consent
- Age 18 or older
- Rutherford Classification of 3-5
- Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath
- Femoro-popliteal lesions ≥10 cm in length considered to be:
- Chronic total occlusion (100% stenosis)
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- Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
- In-stent restenosis (>50% stenosis)
- Proximal and distal target vessels are 5.4-7.0 mm in diameter
- Orifice and proximal 1 cm of SFA is patent
- Patent popliteal artery 3 cm proximal to tibial plateau
- At least 1 patent tibial artery to the foot
- Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein
- Subject has > one year life expectancy
Who cannot join
- Bypass length required > 30 cm
- History of deep vein thrombosis
- Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
- Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
- Pregnant or nursing
- Untreated flow-limiting aortoiliac occlusive disease
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- Has renal failure (eGFR < 30mL/min)
- Major distal amputation (above the transmetatarsal) in the study or non-study limb
- Patient has had a revascularization procedure on the target limb within 30 days
- Patient has a planned amputation of the target limb
- Previous bypass surgery on the target limb
- Patient is participating in another clinical study for which follow-up is currently on going.
- Patient has a condition that in the view of the investigator precludes participation in this study
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Poland3 sites
Gdansk Medical University
Gdansk
Poznan University of Medical Sciences
Poznan, 61-848
Institute of Haematology Medicine Indira Gandhi
Warsaw
About this study
Official title: PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Read the detailed description
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
- Conditions
- Peripheral Arterial Disease
- Being tested
- PQ Bypass System for Femoropopliteal Bypass
- 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.
PQ Bypass System for Femoropopliteal BypassDevice
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass Receives: Device: PQ Bypass System for Femoropopliteal Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions With Primary Patency
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).
Measured: 6 Months
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
Measured: One Month
Secondary outcomes (8)
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure
Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure
Measured: One Month
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure
Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).
Measured: 12 Months
Major Adverse Vascular Event (MAVE) Rate
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion >2 units, and symptomatic deep vein thrombosis on ipsilateral limb
Measured: One Month
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb
Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.
Measured: One Month
Number of Major Adverse Events at the 12-Month Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Measured: 12 Months
Number of Major Adverse Events at the 3 Year Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Measured: 3 Years
Major Adverse Vascular Event (MAVE) Rate at 3 Years
Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion >2 units, and symptomatic deep vein thrombosis on ipsilateral limb.
Measured: 3 Years
Technical Success
Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system.
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2018
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, PhD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471638
- Sponsor's protocol ID
- STP 115
- Acronym
- DETOUR1
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2015
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schneider PA, Krievins DK, Halena G, Schmidt A, Lyden S, Lee V, Hu M, Adelman M. Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8.
PubMed 33429092Krievins DK, Halena G, Scheinert D, Savlovskis J, Szopinski P, Kramer A, Ouriel K, Nair K, Holden A, Schmidt A. One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.
PubMed 32276015
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
- ClinicalTrials.gov ID
- NCT02471638
- Acronym / sponsor ID
- DETOUR1 / STP 115
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Detailed description
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: PQ Bypass System for Femoropopliteal BypassPQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide informed consent
- Age 18 or older
- Rutherford Classification of 3-5
- Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath
- Femoro-popliteal lesions ≥10 cm in length considered to be:
Key exclusion criteria (13 listed)
- Bypass length required > 30 cm
- History of deep vein thrombosis
- Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
- Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
- Pregnant or nursing
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 |
|---|---|---|
| PQ Bypass System for Femoropopliteal BypassTo access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass. | Device | Single arm study |
Primary outcome
Number of Lesions With Primary Patency
Time frame: 6 Months
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
Time frame: One Month
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
8 secondary outcomes
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure
Time frame: One Month
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure
Time frame: 12 Months
Major Adverse Vascular Event (MAVE) Rate
Time frame: One Month
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb
Time frame: One Month
Number of Major Adverse Events at the 12-Month Time Point
Time frame: 12 Months
Number of Major Adverse Events at the 3 Year Time Point
Time frame: 3 Years
Major Adverse Vascular Event (MAVE) Rate at 3 Years
Time frame: 3 Years
Technical Success
Time frame: Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33429092Schneider PA, Krievins DK, Halena G, Schmidt A, Lyden S, Lee V, Hu M, Adelman M. Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8.
- Derived from this study: PubMed 32276015Krievins DK, Halena G, Scheinert D, Savlovskis J, Szopinski P, Kramer A, Ouriel K, Nair K, Holden A, Schmidt A. One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dierk Scheinert, PhD principal investigator
University of Leipzig
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PQ Bypass System for Femoropopliteal Bypass in people with Peripheral Arterial Disease, run by Endologix at 8 sites in 6 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 14 inclusion and 13 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, Chile, Germany, Italy, Latvia and 1 more country. 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 23 May 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?
Number of Lesions With Primary Patency (time frame: 6 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 NCT02471638, which also lists 2 linked publications.
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 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.