Clinical trial NCT02471638: DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
Official title: PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Lesions With Primary Patency
timeFrame: 6 Months
measure: Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
timeFrame: One Month
Secondary outcomes:
measure: Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure
timeFrame: One Month
measure: Percentage of Lesions With Primary Patency at 12 Months Post-Procedure
timeFrame: 12 Months
measure: Major Adverse Vascular Event (MAVE) Rate
timeFrame: One Month
measure: Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb
timeFrame: One Month
measure: Number of Major Adverse Events at the 12-Month Time Point
timeFrame: 12 Months
measure: Number of Major Adverse Events at the 3 Year Time Point
timeFrame: 3 Years
measure: Major Adverse Vascular Event (MAVE) Rate at 3 Years
timeFrame: 3 Years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Católica de Chile
city: Leipzig
country: Germany
facility: University of Leipzig Medical Centre
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Riga
country: Latvia
facility: Stradins University Hospital
city: Auckland
country: New Zealand
facility: Vascular Service
city: Gdańsk
country: Poland
facility: Gdansk Medical University
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Warsaw
country: Poland
facility: Institute of Haematology Medicine Indira Gandhi
Study officials:
affiliation: University of Leipzig
name: Dierk Scheinert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Krievins 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.