Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT05175703
Eligibility Criteria:
Inclusion Criteria:
* Person over 19 years old who is recognized as an adult in the civil law
* Person willing to sign a subject written consent
* Patient having infrainguinal arterial lesion that is adequate to intravascular treatment using Passeo-18 Lux Paclitaxel releasing Balloon Catheter
* Peripheral arterial disease in 2-5 grade of Rutherford
* Patient without at least one of significant lesions (≥50% of stenosis) in distal leaking artery. When there is at least one of opening blood vessels under the knee in treatment of arterial popliteal or at least one of opening cural vessel under the ankle in arterial treatment under the knee. Treatment of inflow arterial disease is allowed before the relevant treatment.)
Exclusion Criteria:
* Life expectancy ≤ 1 year
* Patient who is currently under medication of an investigation drug or treatment by a device that did not reach the primary endpoints.
* Subject during pregnancy or having a plan of pregnancy during the study period
* A guide wire could not passed into the target lesion (Successful passage of guide wire means its movement into the distal part of target lesion without causing arterial dissection or perforation by the end of guidewire.)
* Acute thrombosis is accompanied
* Major amputation is planned There is medical history of bypass surgery on target vessel
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05175703
Study Brief:
Protocol Section:
NCT05175703