A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Dr… (NCT07385573) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions
200 participantsStarted 2026-06
Plain-language summary
This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.
The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards.
This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.
Who can participate
Age range
18 Years – 99 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
* Study participant is ≥ 18 years and ≤ 99 years old
* Lesion(s) in the infrainguinal arteries:
* Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
* Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau
* RVD 2-7mm
* De novo stenotic, restenotic post POBA, or occlusive lesion(s)
* Target lesion must have angiographic evidence of ≥70% stenosis
* Lesion length ≥ 3cm
* Successful crossing of the target lesion with the guide wire
* Successful predilatation, defined as residual stenosis \<50% Rutherford Class 2-5
* Study participant is able to provide consent and has signed and dated the informed consent form
Exclusion criteria
* Life expectancy ≤ 1 year
* Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
* Study participant is pregnant, planning to become pregnant, or father children during the course of the study.
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).
* Prior bypass surgery of target vessel
* Planned major amputation of the target limb
* Thrombus in the target vessel
* Known allergy to contrast media that cannot be adequately controlled with premedication
* Study participant has a single target lesion that involves both ATK and BTK segments
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
Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.
Timeframe: 12-months post-index procedure
2
Freedom from Major Adverse Events (MAE) through 12 months