PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
NCT ID: NCT00715416
Last Updated: 2008-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
76 participants
INTERVENTIONAL
2004-06-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
primary nitinol stent placement of superficial femoral artery lesions
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.
Nitinol Stent Placement
Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
2
balloon angioplasty of superficial artery lesions with secondary stent placement in case of \>30% residual stenosis after the procedure
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.
Interventions
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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.
Nitinol Stent Placement
Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* critical limb ischemia in patients with stenosis or occlusions originating in the SFA
* up to 25 cm length of stenosis/occlusion
Exclusion Criteria
* 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
ALL
No
Sponsors
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Vienna General Hospital
OTHER
Responsible Party
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General Hospital of Vienna
Principal Investigators
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Martin Schilliger, Prof
Role: PRINCIPAL_INVESTIGATOR
General Hospital of Vienna, Department of Angiology
Martin Schillinger, Prof
Role: PRINCIPAL_INVESTIGATOR
General Hospital of Vienna
Locations
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University Hospital of Vienna
Vienna, Vienna, Austria
Countries
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References
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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. doi: 10.1056/NEJMoa051303.
Other Identifiers
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1.1/2006
Identifier Type: -
Identifier Source: org_study_id