Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrai… (NCT05175703) | Clinical Trial Compass
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Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries
South Korea200 participantsStarted 2018-03-05
Plain-language summary
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment.
Research institute for enrollment, and period; It is planned to enroll about 200 subjects in 9 domestic research institutes. It is expected to require about 12-18 months to enroll the subjects.
Subject follow-up schedule; Perform follow-up by phone call or clinical assessment at 1, 6, 12, and 24 months of the postoperative time point
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.