NCT00715416

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Vienna General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Vascular Diseases
• Intermittent Claudication
• Angioplasty

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-07-15
• Last updated: 2008-07-15

Locations

1 site across 1 country: Austria