Long Passeo-18 Lux balloon for leg artery blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses the Passeo-18 Lux drug-coated balloon to treat infrainguinal restenotic, occlusive, or new lesions in the lower leg arteries. It is a non-randomized, interventional study conducted at several European sites to gather additional safety and performance data for longer balloon lengths. Participants must have significant arterial narrowing (≥70% stenosis) and lesion length of at least 3 cm, with successful lesion crossing and predilatation. Outcomes focus on device safety and the rate of successful treatment in routine clinical care. The device already has CE marking and prior safety data in Europe, but this trial aims to confirm its effectiveness and safety in real-world use, particularly for longer lengths.

Why it matters

Who can join: the full rules

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

Where it's running

• Azorg
  Aalst, Belgium Recruiting
• Imelda Ziekenhuis
  Bonheiden, Belgium Recruiting
• AZ Sint Blasius
  Dendermonde, Belgium Recruiting
• ZOL Genk
  Genk, Belgium Recruiting

Study contacts

• Study coordinator: Anke Van Roost
• Email: anke.vanroost@xperresearch.com
• Phone: +32 498 72 27 08

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.