N/A
N=78
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT02471638 ↗Enrolled (actual)
78
Serious AEs
18.0%
Results posted
May 2025
Primary outcome: Primary: Number of Lesions With Primary Patency — 72 Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PQ Bypass System for Femoropopliteal Bypass (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endologix
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions With Primary Patency |
72 | — |
| PRIMARY Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure |
2; 79 | — |
| SECONDARY Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure |
0; 2; 0; 79 | — |
| SECONDARY Percentage of Lesions With Primary Patency at 12 Months Post-Procedure |
81 | — |
| SECONDARY Major Adverse Vascular Event (MAVE) Rate |
3; 0; 0; 0; 1; 77 | — |
| SECONDARY Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb |
1; 80 | — |
| SECONDARY Number of Major Adverse Events at the 12-Month Time Point |
1; 12; 0; 66 | — |
| SECONDARY Number of Major Adverse Events at the 3 Year Time Point |
3; 1; 27 | — |
| SECONDARY Major Adverse Vascular Event (MAVE) Rate at 3 Years |
15; 0; 0; 0; 1; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02471638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.