RecruitingNot ApplicableNCT07385573

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

Sponsor

KANDO Research

Enrollment

200 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease Drug-coated Balloon

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB for people with drug-coated balloon and peripheral arterial disease. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPercutaneous 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.