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PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

This study has been completed.
Sponsor:
Information provided by:
Vienna General Hospital
ClinicalTrials.gov Identifier:
NCT00715416
First received: July 11, 2008
Last updated: NA
Last verified: January 2006
History: No changes posted

July 11, 2008
July 11, 2008
June 2004
February 2008   (final data collection date for primary outcome measure)
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Vascular Diseases
  • Intermittent Claudication
  • Angioplasty
  • Device: Nitinol stent
    Interventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram.
  • Procedure: Nitinol Stent Placement
    Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
    Other Names:
    • Product: peripheral stent system
    • Type: ASTRON
    • EC class: IIb
    • Certificate number: G1 01 10 10275 193
    • EC number: 0123
    • Date of issue: 26.10.2001
  • Experimental: 1
    primary nitinol stent placement of superficial femoral artery lesions
    Interventions:
    • Device: Nitinol stent
    • Procedure: Nitinol Stent Placement
  • Active Comparator: 2
    balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure
    Intervention: Device: Nitinol stent
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
  • critical limb ischemia in patients with stenosis or occlusions originating in the SFA
  • up to 25 cm length of stenosis/occlusion

Exclusion Criteria:

  • previous bypass surgery at the site of treatment
  • history of intolerance of anti-platelet therapy
  • adverse reaction to heparin
  • bleeding diathesis
  • creatinine >2.5 mg/dL
  • active bacterial infection
  • allergy to contrast media
  • previous stent placement at or immediately adjacent to the target lesion
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00715416
1.1/2006
No
Prof. Martin Schillinger, General Hospital of Vienna
Vienna General Hospital
Not Provided
Principal Investigator: Martin Schilliger, Prof General Hospital of Vienna, Department of Angiology
Principal Investigator: Martin Schillinger, Prof General Hospital of Vienna
Vienna General Hospital
January 2006

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