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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Lesions With Primary Patency
Timeframe: 6 Months
2
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure