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Clinical Trials/NCT00715416
NCT00715416CompletedPhase 4

Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

Vienna General Hospital2 sites in 1 country76 target enrollmentStarted: June 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
76
Locations
2
Primary Endpoint
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure(3, 6, 12 months)

Investigators

Sponsor
Vienna General Hospital
Sponsor Class
Other

Study Sites (2)

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