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

Phase 4

Completed

• Conditions: Intermittent Claudication; Peripheral Vascular Diseases; Angioplasty
• Interventions: Device: Nitinol stent; Procedure: Nitinol Stent Placement

• Registration Number: NCT00715416
• Lead Sponsor: Vienna General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Status Verified: 2006-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Last Update Submitted: 2008-07-11
• Study First Posted: 2008-07-15
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nitinol Stent Placement	primary nitinol stent placement of superficial femoral artery lesions
1	Nitinol stent	primary nitinol stent placement of superficial femoral artery lesions
2	Nitinol stent	balloon angioplasty of superficial artery lesions with secondary stent placement in case of \>30% residual stenosis after the procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Vienna; 🇦🇹 Vienna, Austria