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 (LUX-PAD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Drug Coated Balloon
• Intervention / Treatment: Procedure: Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passeo-18 Lux Arm; All trial participants will be treated with the same Passeo-18 Lux drug coated balloon (which comes in different sizes).	Procedure: Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-months post-index procedure
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.	Through 12 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During index procedure
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.	After index procedure
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.	At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months
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.	At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months
Amputation-free survival (AFS: alive without major amputation)	Amputation-free survival (AFS) is defined as being alive without major amputation.	At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months
Freedom from Major Target Limb Amputation	Major target limb amputation is defined as any amputation above the ankle in the target limb.	At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months
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.	At scheduled follow-up visits: 1, 6, 12, and 24 months
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.	At scheduled follow-up visits: 1, 6, 12, and 24 months
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.	At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months
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).	At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months
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.	At scheduled follow-up visits: 1, 12, and 24 months
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).	At scheduled follow-up visits: 1, 12, and 24 months
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	at 1, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: KANDO Research

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LUX-PAD; Passeo-18 Lux Long; Passeo-18
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Angioplasty
• Other Study ID Numbers: LUX-PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to participant privacy concerns and because data sharing was not included in the informed consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No