Clinical Trial

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

Study acronym: LUX-PAD
Not Yet Recruiting
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-04-30
notable Primary completion pushed: 2027-09 -> 2028-01 2026-04-30
minor Completion moved earlier: 2032-09 -> 2032-01 2026-04-30
Trial Details
NCT Number NCT07385573
Lead Sponsor KANDO Research
Conditions Drug Coated Balloon, Peripheral Arterial Disease
Enrollment 200 participants
Start Date 2026-06
Primary Completion 2028-01 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09