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
Study ID
NCT07385573
Status
Not Yet Recruiting

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Conditions

  • Drug Coated Balloon
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Feb 4, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure. [ Time Frame: 12-months post-index procedure ]

Central Contacts

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