Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy (NCT05529472) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
Japan81 participantsStarted 2023-01-10
Plain-language summary
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.
Who can participate
Age range
18 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.
General Inclusion Criteria (≤30 Days from Clinical Trial Treatment):
* 18 years of age or older
* Subject has signed the approved KAIZEN study Informed Consent Form prior to any study-related procedures
* Chronic, symptomatic lower limb ischemia
* Clinical indication for percutaneous transluminal angioplasty intervention in the native SFA and/or POP artery
General Exclusion Criteria (≤30 Days from Clinical Trial Treatment):
* Female who is pregnant and/or breastfeeding
* Currently participating in another investigational clinical study
* Unwilling to follow the Investigator's instructions or follow-up requirements
* Any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment
* Any non-diagnostic coronary intervention within 30 days before clinical trial treatment
* Any planned non-diagnostic vascular intervention(s) within 30 days after clinical trial treatment
* Any planned procedures or other medical conditions which, in the Investigator's opinion, may interfere with the study result and/or subject's optimal participation in the study
* Prior major amputation within one year of the clinical trial treatment procedure
* Planned major amputation
* Life expectancy of ≤6 months
* History of coagulopathy or hypercoagulable bleeding disorder
* History of Myocardial Infarction (MI), or stroke/cerebrovascular accident within 6-months prior to the clinical trial treatment
* Unstable angina pectoris
*…
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.