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

PHASE4CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Peripheral Vascular DiseasesIntermittent ClaudicationAngioplasty
Interventions
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

Trial Locations (1)

1090

University Hospital of Vienna, Vienna

All Listed Sponsors
lead

Vienna General Hospital

OTHER

NCT00715416 - PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents | Biotech Hunter | Biotech Hunter