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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
IDev Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01154751
First received: June 29, 2010
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Femoropopliteal Artery Stenosis
Peripheral Vascular Disease
 Device: SUPERA Interwoven self-expanding nitinol stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Supera Treatment Registry Observing Neointimal Growth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IDev Technologies, Inc.:

Primary Outcome Measures:
  • Target Lesion Revascularization [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: Yes ]
    Target Lesion Revascularizatio (TLR)rates measured at 6 months and 1 year


Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device SUPERA Stent
SUPERA Interwoven Self-Expanding Nitinol Stent System
 Device: SUPERA Interwoven self-expanding nitinol stent
Insertion of stent at stenotic area
Other Name: SUPERA Interwoven Self-Expanding Nitinol Stent

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 complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  • Target lesion length > 20 cm
  • Instent restenotic / reoccluded target lesion
  • Acute (≤ 4 weeks) thrombotic occlusion
  • Untreated ipsilateral pelvic stenosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154751

Locations
Germany
Herzzentrum Abteilung fur Angiologie
Bad Krozingen, Germany, 79189
Heart Center Leipzig/Park Hospital
Leipzig, Germany, 04289
Kathlisches Klinikum Mainz
Mainz, Germany, 55131
Zentrum fur Diabetes-und GefaBerkrankungen
Munster, Germany, 48145
Sponsors and Collaborators
IDev Technologies, Inc.
Investigators
Principal Investigator: Thomas Zeller, Prof Dr med Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
  More Information

No publications provided

Responsible Party: IDev Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01154751     History of Changes
Other Study ID Numbers: IDEV Technologies, Inc.
Study First Received: June 29, 2010
Last Updated: August 16, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by IDev Technologies, Inc.:
Femoral artery stenosis
Peripheral vascular Disease

Additional relevant MeSH terms:
Constriction, Pathologic
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathological Conditions, Anatomical
 Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on June 18, 2013