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

NCT00715416 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2008-07-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vienna General Hospital

    lead OTHER

Principal Investigators

  • Martin Schilliger, Prof · General Hospital of Vienna, Department of Angiology

  • Martin Schillinger, Prof · General Hospital of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715416 on ClinicalTrials.gov