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

June 29, 2010
August 16, 2012
November 2008
August 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01154751 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Supera Treatment Registry Observing Neointimal Growth

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Artery Disease
  • Femoropopliteal Artery Stenosis
  • Peripheral Vascular Disease
Device: SUPERA Interwoven self-expanding nitinol stent
Insertion of stent at stenotic area
Other Name: SUPERA Interwoven Self-Expanding Nitinol Stent
Device SUPERA Stent
SUPERA Interwoven Self-Expanding Nitinol Stent System
Intervention: Device: SUPERA Interwoven self-expanding nitinol stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2015
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01154751
IDEV Technologies, Inc.
No
IDev Technologies, Inc.
IDev Technologies, Inc.
Not Provided
Principal Investigator: Thomas Zeller, Prof Dr med Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
IDev Technologies, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP