Angioplasty, Intermittent Claudication, Peripheral Vascular Diseases
Conditions
Keywords
peripheral vascular diseases, Intermittent Claudication, Angioplasty
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.
Interventions
DEVICENitinol 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.
PROCEDURENitinol Stent Placement
Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
Sponsors
Vienna General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Austria
Outcome results
None listed