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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 14, 2005 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00172458 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents | ||||
| Official Title ICMJE | Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents | ||||
| Brief Summary | Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Various surgical procedures have been described for the treatment of proximal VAS with symptoms refractory to medical therapy, but all are technically difficult with high operative mortality and morbidity. Endovascular intervention has been described as an alternative to surgery. Balloon angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon angioplasty, and primary stenting have been shown to be safe and effective with lower restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the artery and location of the lesion. Recently, Albuquerque et al. reports a relative high restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue regarding the patients’ quality of life. However, there is no clinical parameter to predict restenosis of VAS. The purpose of this study is to evaluate the clinical results of our series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary stents. We sought to identify predictors of restenosis. This is a clinical observation study. Only chart review and angiographic review will be performed. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Retrospective Study | ||||
| Condition ICMJE | Vertebral Artery Stenosis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients with symptomatic vertebral artery stenosis treated by stenting Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00172458 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 9361700454 | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | August 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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