Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Periphe… (NCT04229563) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
United States102 participantsStarted 2020-08-04
Plain-language summary
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
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.
Inclusion criteria
. Subject is ≥ 18 years old.
. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
. Subject is capable and willing to comply with the scheduled follow up
. Subject is able and willing to sign a written Informed Consent Form (ICF).
Exclusion criteria
. Target lesion is in an arterial bypass.
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.
What they're measuring
1
Primary Efficacy: Acute Procedural Success
Timeframe: Peri-procedural (by the end of the index procedure)
2
Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE)
Timeframe: Through discharge, an average of 5 days
. Planned use of another atherectomy device in the same procedure
. Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study.
. Participating in another study on an interventional non-cleared device, that could impact the study results