This trial is active, not recruiting.

Conditions peripheral artery disease, femoropopliteal artery stenosis, peripheral vascular disease
Treatment supera interwoven self-expanding nitinol stent
Sponsor IDev Technologies, Inc.
Start date November 2008
End date August 2012
Trial size 200 participants
Trial identifier NCT01154751, IDEV Technologies, Inc.


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
SUPERA Interwoven Self-Expanding Nitinol Stent System
supera interwoven self-expanding nitinol stent SUPERA Interwoven Self-Expanding Nitinol Stent
Insertion of stent at stenotic area

Primary Outcomes

Target Lesion Revascularization
time frame: 6 months and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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 aspirin therapy sensitivities - Patient is participating in a clinical study that could confound results - Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry. (Angiographic) - Target lesion length > 20 cm - Instent restenotic / reoccluded target lesion - Acute (≤ 4 weeks) thrombotic occlusion - Untreated ipsilateral pelvic stenosis

Additional Information

Official title Supera Treatment Registry Observing Neointimal Growth
Principal investigator Thomas Zeller, Prof Dr med
Description This registry follows up to 200 patients for at least 5 years. The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by IDev Technologies, Inc..