PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
This study has been completed.
Sponsor:
Vienna General Hospital
Information provided by:
Vienna General Hospital
ClinicalTrials.gov Identifier:
NCT00715416
First received: July 11, 2008
Last updated: NA
Last verified: January 2006
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Diseases Intermittent Claudication Angioplasty |
Device: Nitinol stent Procedure: Nitinol Stent Placement |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Vienna General Hospital:
Primary Outcome Measures:
- occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 76 |
| Study Start Date: | June 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715416
Locations
| Austria | |
| University Hospital of Vienna | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
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 |
More Information
Publications:
| Responsible Party: | Prof. Martin Schillinger, General Hospital of Vienna |
| ClinicalTrials.gov Identifier: | NCT00715416 History of Changes |
| Other Study ID Numbers: | 1.1/2006 |
| Study First Received: | July 11, 2008 |
| Last Updated: | July 11, 2008 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Vienna General Hospital:
|
peripheral vascular diseases Intermittent Claudication Angioplasty |
Additional relevant MeSH terms:
|
Intermittent Claudication Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arteriosclerosis |
Arterial Occlusive Diseases Cardiovascular Diseases Signs and Symptoms Atherosclerosis |
ClinicalTrials.gov processed this record on June 18, 2013