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Completed

NCT Number: NCT02471638

DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica de Chile, Santiago, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

PQ Bypass System for Femoropopliteal Bypass

Device

To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure

    Time frame: One Month

    Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure

  2. Percentage of Lesions With Primary Patency at 12 Months Post-Procedure

    Time frame: 12 Months

    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).

  3. Major Adverse Vascular Event (MAVE) Rate

    Time frame: One Month

    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

  4. Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb

    Time frame: One Month

    Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.

  5. Number of Major Adverse Events at the 12-Month Time Point

    Time frame: 12 Months

    Number of occurrences of all cause death, CD-TVR, or major target limb amputation

  6. Number of Major Adverse Events at the 3 Year Time Point

    Time frame: 3 Years

    Number of occurrences of all cause death, CD-TVR, or major target limb amputation

  7. Major Adverse Vascular Event (MAVE) Rate at 3 Years

    Time frame: 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.

  8. Technical Success

    Time frame: Index Procedure

    Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)

Acronym: DETOUR1

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 15, 2015
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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