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

Anke Van Roost

CONTACT

Lead Sponsor

KANDO Research

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

•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

•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

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