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

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

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 Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases; Intermittent Claudication; Angioplasty
• Intervention / Treatment: Device: Nitinol stent; Procedure: Nitinol Stent Placement

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • University Hospital of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; primary nitinol stent placement of superficial femoral artery lesions	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; Other Names: Product: peripheral stent system; Type: ASTRON; EC class: IIb; Certificate number: G1 01 10 10275 193; EC number: 0123; Date of issue: 26.10.2001
Active Comparator: 2; balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vienna General Hospital
• Investigators: Principal Investigator: Martin Schilliger, Prof, General Hospital of Vienna, Department of Angiology; Principal Investigator: Martin Schillinger, Prof, General Hospital of Vienna

Publications and helpful links

General Publications

• Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 15, 2008
• Last Update Submitted That Met QC Criteria: July 11, 2008
• Last Verified: January 1, 2006

More Information

Terms related to this study

• Keywords: Angioplasty; Intermittent Claudication; peripheral vascular diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 1.1/2006