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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty

Intervention / Treatment
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* Device: Nitinol stent
* Procedure: Nitinol Stent Placement


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>primary nitinol stent placement of superficial femoral artery lesions | Device: Nitinol stent<br>* 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.<br>Procedure: Nitinol Stent Placement<br>* Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions<br>* Other names: Date of issue: 26.10.2001;|
| Active Comparator: 2<br>balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure | Device: Nitinol stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). |  | 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral vascular diseases, Intermittent Claudication, Angioplasty