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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 30, 2005 | ||||
| Last Updated Date | May 2, 2007 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Final residual diameter stenosis < 50% by Quantatative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00231283 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Composite of MACE defined as death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR) at discharge and 30 days post-procedure. [ Time Frame: Discharge and 30 days post-procedure ] | ||||
| Original Secondary Outcome Measures ICMJE |
Composite of MACE defined as death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR) at discharge and 30 days post-procedure. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions | ||||
| Official Title ICMJE | A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions | ||||
| Brief Summary | The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00231283 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P04-6324 | ||||
| Study Sponsor ICMJE | Cordis Corporation | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Cordis Corporation | ||||
| Verification Date | May 2007 | ||||
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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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