NCT07385573

Evaluation of the Safety and Efficacy of the Long (> 150mm) Passeo-18 Lux Drug-coated Balloon of Teleflex in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery

A Single Arm Controlled Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) Passeo-18 Lux Drug-coated Balloon of Teleflex in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: KANDO Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2032-09-01
• First posted: 2026-02-04
• Last updated: 2026-02-04