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NCT Number: NCT07385573

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

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.

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Key information

Conditions

Drug Coated Balloon Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

This intervention uses the 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.

Primary outcomes

  1. Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.

    Time frame: 12-months post-index procedure

    The primary clinical performance endpoint is Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.

  2. Freedom from Major Adverse Events (MAE) through 12 months

    Time frame: Through 12 months post-index procedure

    The primary safety endpoint is freedom from major adverse events (MAE), defined as a composite of freedom from device- or procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR, within 12 months post-index procedure.

Secondary outcomes

  1. Successful delivery, inflation, deflation, and retrieval of the intact study device during index procedure.

    Time frame: During index procedure

    Device success is defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure.

  2. Restoration of target lesion with ≤30% residual stenosis in final angiogram.

    Time frame: After index procedure

    Procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.

  3. Number of deaths from any cause (all-cause mortality) at 1, 6, 12, 24, 36, 48, and 60 months

    Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

    All-cause mortality is defined as the total number of deaths from any cause among study participants at each scheduled follow-up time point.

  4. Primary patency of target lesion (freedom from clinically driven target lesion revascularization [fcd-TLR] and binary restenosis)

    Time frame: At scheduled follow-up visits: 1, 6, 12, and 24 months

    Primary patency is defined as a composite of freedom from clinically driven target lesion revascularization (fcd-TLR) and binary restenosis, where restenosis is defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab.

  5. Freedom from Clinically-driven Target Lesion Revascularization (fcd-TLR)

    Time frame: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months

    Clinically driven target lesion revascularization (fcd-TLR) is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms.

  6. Freedom from Clinically-driven Target Vessel Revascularization (TVR)

    Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

    Clinically driven TLR is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.

  7. Freedom from major adverse events (MAE: device- or procedure-related mortality, major target limb amputation, and clinically driven TLR)

    Time frame: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months

    Major adverse events (MAE) are defined as a composite of freedom from device- or procedure-related mortality through 30 days, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (TLR).

  8. Amputation-free survival (AFS: alive without major amputation)

    Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

    Amputation-free survival (AFS) is defined as being alive without major amputation.

  9. Freedom from Major Target Limb Amputation

    Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

    Major target limb amputation is defined as any amputation above the ankle in the target limb.

  10. Change from baseline in Rutherford classification at 1, 6, 12, and 24 months

    Time frame: At scheduled follow-up visits: 1, 6, 12, and 24 months

    Change from baseline in Rutherford classification will be assessed to evaluate the severity of ischemia in the lower extremities among study participants.

  11. Change from baseline in EQ-5D quality of life score at 1, 12, and 24 months

    Time frame: At scheduled follow-up visits: 1, 12, and 24 months

    Change from baseline in health-related quality of life, as assessed by the EQ-5D questionnaire, will be evaluated among study participants.

  12. Change from baseline in Walking Impairment Questionnaire (WIQ) score at 1, 12, and 24 months

    Time frame: At scheduled follow-up visits: 1, 12, and 24 months

    Change from baseline in functional limitations, as assessed by the Walking Impairment Questionnaire (WIQ), will be evaluated among study participants with peripheral artery disease (PAD).

  13. Change from baseline in ABI at 1, 6, 12, and 24 months

    Time frame: at 1, 6, 12, and 24 months

    ABI is defined as Ankle-Brachial Index (ABI) measurement of the limb being treated

Study contacts

Contact information is provided by the study sponsor or research team.

Anke Van Roost

CONTACT

[email protected]

+32 498 72 27 08

Sponsors and collaborators

Lead sponsor

KANDO Research

Other

Registry information

Acronym: LUX-PAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Feb 4, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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