Data Registry Following Patients Using Supera Stent in the Femoral Arteries (NCT01154751) | Clinical Trial Compass
TerminatedNot Applicable
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Stopped: Slow enrollment,increased loss to follow-ups and general lack of interest.
Germany200 participantsStarted 2008-11
Plain-language summary
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
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.
Exclusion Criteria:
(Clinical)
* Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
* Rutherford-Becker classification 2 through 5 only
* Patient is at least 18 years of age and of legal age of consent.
* Patient must be willing to participate in the registry for at least 5 years.
(Angiographic)
* Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
* All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
* All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
* Target lesion length 1-20 cm (visual estimate)
* Target lesion stenosis ≥50% (visual estimate)
* Popliteal artery patent if the lesion is in the SFA
* SFA patent if the lesion is in the popliteal artery
* At least one widely patent (\< 50% stenosis) infrapopliteal artery (for distal run-off)
Exclusion Criteria:
(Clinical)
* Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or as…
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.