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

NCT07385573 | Not Yet Recruiting

• 1 other identifier: LUX-PAD
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Drug Coated Balloon; Peripheral Arterial Disease

Keywords

LUX-PAD; Passeo-18 Lux Long; Passeo-18

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

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

  During index procedure

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

  After index procedure

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

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

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

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

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

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

Study Arms (1)

Passeo-18 Lux Arm

EXPERIMENTAL

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

Interventions

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.

Passeo-18 Lux Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KANDO Research: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Anke Van Roost

CONTACT

+32 498 72 27 08; anke.vanroost@xperresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share