Data Registry Following Patients Using Supera Stent in the Femoral Arteries (STRONG)

Abbott

Status

Terminated

Conditions

Peripheral Vascular Disease

Peripheral Artery Disease

Femoropopliteal Artery Stenosis

Treatments

Device: SUPERA Interwoven self-expanding nitinol stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01154751

IDEV Technologies, Inc.

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)