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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00715416
Other study ID # 1.1/2006
Secondary ID
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


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
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