Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System (NCT04282161) | Clinical Trial Compass
WithdrawnNot Applicable
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
Stopped: Business Decision
0Started 2021-12
Plain-language summary
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.
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
. Rutherford Clinical Category (RCC) Score of 2 - 5
. Willing and capable of complying with all follow-up evaluations at the specified times
. Age ≥ 18 years old
. Provides written informed consent prior to study specific procedures
. Completed Ankle/Brachial Index (ABI) (or Toe/Brachial Index \[TBI\]) prior to index procedure (up to 60 days prior)
. Evidence of ≥ 70% stenosis or occlusion in the peripheral vasculature of the target vessel, confirmed by angiography
. Target lesion present in a single limb that consists of a single de novo or non-stented restenotic lesion, or qualifies as a tandem or combination lesion per the definitions below:
. Tandem (adjacent) Lesion: Lesions present in the same target vessel that can be treated as one single lesion and is separated by an angiographic normal vessel ≤3 cm at any point. Multiple points of separation can be present in single lesion treatment if no single point of separation is \> 3 cm
Exclusion criteria
3. Has one or more of the contraindications listed in the Axys EX Rotational Atherectomy System's IFU
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.