Treatment of Calcific Total Occlusions in Peripheral Artery Disease (NCT05551780) | Clinical Trial Compass
RecruitingNot Applicable
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
United States, Austria, Germany130 participantsStarted 2023-02-21
Plain-language summary
Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.
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
. Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:
. CaTO-PAD: infrainguinal
. CaTO-BTK: infrapopliteal
. Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation
. Presenting with the following:
. CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
. CaTO-BTK Sub-Study: - Category 4 or 5 only for CaTO-BTK Sub-Study CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
. Age of \> 18 years
Exclusion criteria
. Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:
. Glomerular filtration rate \<30 ml/min
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.
. Already enrolled in an investigational interventional study that would interfere with study endpoints
. Target lesion is crossed intraluminally with a conventional guidewire
. Treatment of an inflow lesion prior to target lesion treatment results in no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment