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

Intermittent Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715416
• Other study ID #: 1.1/2006
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2008
• Last updated: July 11, 2008
• Start date: June 2004
• Est. completion date: February 2008

Study information

• Verified date: January 2006
• Source: Vienna General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Austria	University Hospital of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna General Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).		3, 6, 12 months	Yes
Secondary	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	Yes