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 range18 Years
SexALL
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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…