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Status:

TERMINATED

Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Lead Sponsor:

Abbott Medical Devices

Conditions:

Peripheral Artery Disease

Femoropopliteal Artery Stenosis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

Detailed 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 co...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2015

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT01154751

    Start Date

    November 1 2008

    End Date

    August 1 2015

    Last Update

    September 19 2017

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Herzzentrum Abteilung fur Angiologie

    Bad Krozingen, Germany, 79189

    2

    Heart Center Leipzig/Park Hospital

    Leipzig, Germany, 04289

    3

    Kathlisches Klinikum Mainz

    Mainz, Germany, 55131

    4

    Zentrum fur Diabetes-und GefaBerkrankungen

    Münster, Germany, 48145