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Drug Coated BalloonLUX-PADNCT07385573

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

A study testing Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB in people with Drug Coated Balloon and Peripheral Arterial Disease, run by KANDO Research at 4 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesBelgium
Study dates
1 Jul 2026to Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anke Van Roost contact

+32 498 72 27 08

anke.vanroost@xperresearch.com

Belgium4 sites, 4 recruiting

  • AZORG

    Aalst

    Hilde Keymeulen, +32 53 72 41 60, klinischestudies@azorg.be

    Recruiting

  • Imelda Ziekenhuis

    Bonheiden

    Fleur Claes, 015/50.61.82, fleur.claes@imelda.be

    Recruiting

  • AZ Sint Blasius

    Dendermonde

    Marit Dubruel, +32 (0)52 25 27 45, Marit.Dubruel@azsintblasius.be

    Recruiting

  • ZOL Genk

    Genk

    Wendy Zwinnen, 089 80 80 80

    Recruiting

Other trials in Belgium

About this study

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.

Being tested
Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB
Keywords
LUX-PAD, Passeo-18 Lux Long, Passeo-18
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCBProcedure or surgery

    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.

Study groups in NCT07385573
Study groupRoleWhat they receive
Passeo-18 Lux ArmExperimentalAll trial participants will be treated with the same Passeo-18 Lux drug coated balloon (which comes in different sizes).
Receives: Procedure: Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 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.

    Measured: 12-months post-index procedure

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

    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.

    Measured: Through 12 months post-index procedure

Secondary outcomes (13)

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

    Measured: During index procedure

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

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

    Measured: After index procedure

  3. Number of deaths from any cause (all-cause mortality) at 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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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).

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

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

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

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

  9. Freedom from Major Target Limb Amputation

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

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

  10. Change from baseline in Rutherford classification at 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.

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

  11. Change from baseline in EQ-5D quality of life score at 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.

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

  12. Change from baseline in Walking Impairment Questionnaire (WIQ) score at 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).

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

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

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

    Measured: at 1, 6, 12, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start1 Jul 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385573
Sponsor's protocol ID
LUX-PAD
Acronym
LUX-PAD
Status last verified
Sep 2026
First submitted
21 Jan 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to participant privacy concerns and because data sharing was not included in the informed consent.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB in people with Drug Coated Balloon and Peripheral Arterial Disease, run by KANDO Research at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anke Van Roost (+32 498 72 27 08, anke.vanroost@xperresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure. (time frame: 12-months post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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