Evaluation of the Safety and Efficacy of the Long (> 150mm) Passeo-18 Lux Drug-coated Balloon of Teleflex in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery (LUX-PAD)

KANDO Research

Status: Begins enrollment this month

Conditions: Drug Coated Balloon; Peripheral Arterial Disease

Treatments: Procedure: Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB

Study type: Interventional

Funder types: Other

Identifiers

NCT07385573

LUX-PAD

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Lesion(s) in the infrainguinal arteries
2. Reference Vessel Diameter 2-7mm
3. De novo stenotic, restenotic post POBA (the phenomenon where atherosclerotic plaques form in the treated arteries after balloon angioplasty), or occlusive lesion(s)
4. Target lesion must have angiographic evidence of ≥70% stenosis
5. Lesion length ≥ 3cm
6. Successful crossing of the target lesion with the guide wire
7. Successful predilatation, defined as residual stenosis <50% without flow limiting dissection grade D, E or F (Modified Fujihara classification)
8. Rutherford Class 2-5
9. Study participant is able to provide consent and has signed and dated the informed consent form

Exclusion criteria

1. Life expectancy ≤ 1 year
2. Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
3. Study participant is pregnant or planning to become pregnant during the course of the study.
4. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).
5. Prior bypass surgery of target vessel
6. In-stent restenosis
7. Planned major amputation of the target limb
8. Thrombus in the target vessel
9. Known allergy to contrast media that cannot be adequately controlled with premedication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Passeo-18 Lux Arm

Experimental group

Description:

All trial participants will be treated with the same Passeo-18 Lux drug coated balloon (which comes in different sizes).

Treatment:

Procedure: Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB