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

Vienna General Hospital76 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Vascular Diseases Intermittent Claudication Angioplasty

Interventions

Nitinol stentDEVICE

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 PlacementPROCEDURE

Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Vienna

Vienna, State of Vienna, Austria

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

Time frame: 3, 6, 12 months

Data from ClinicalTrials.gov

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