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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014