The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels, using at least one of the products (named above) from Cordis US Corp.
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
. Patient is \>18 years old.
. Target Lesion is located in the infrapopliteal arteries.
. Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.
Exclusion criteria
. Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
. Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
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
Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs
Timeframe: 30 days post procedure
2
Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs
Timeframe: 30 days post procedure
3
Technical success rate
Timeframe: during surgery
4
Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)