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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | primary nitinol stent placement of superficial femoral artery lesions |
|
| 2 | Active Comparator | balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitinol stent | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schilliger, Prof | General Hospital of Vienna, Department of Angiology | Principal Investigator |
| Martin Schillinger, Prof | General Hospital of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Vienna | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16672699 | Background | 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. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D012816 | Signs and Symptoms |
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| Nitinol Stent Placement | Procedure | Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |