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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) | Device | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge | Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion | From post-procedure up to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | From post-procedure up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson Perin, MD | Texas Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Heart Institute | Houston | Texas | 77030 | United States |
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First patient enrolled was Apr 2004 and last patient enrolled was Jul 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYPHER NxT Stent on the BX SONIC OTW SDS | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CYPHER NxT Stent on the BX SONIC OTW SDS | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge | Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion | Patients who were followed up to hospital discharge | Posted | Number | Percentage of Participants | From post-procedure up to hospital discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CYPHER NxT Stent on the BX SONIC OTW SDS | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient (one year) follow-up or who had an event prior to the end of follow-up. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction (Q wave or Non-Q wave) | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sidney Cohen, MD PhD, Vice President | Cordis | 650 614-2726 | scohen7@its.jnj.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge |
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). |
| From post-procedure up to hospital discharge |
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | From post-procedure up to 12 months |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients with Diabetes Mellitus | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | Patients who had 30 days clinical follow-up. | Posted | Number | Percentage of Participants | From post-procedure up to 30 days |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | Patients who were followed up to hospital discharge | Posted | Number | Percentage of participants | From post-procedure up to hospital discharge |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). | Patients who had at least 330 days clinical follow-up. | Posted | Number | Percentage of participants | From post-procedure up to 12 months |
|
|
|
|
| 1 |
| 95 |
| 12 |
| 96 |
|
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| Emergent CABG | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Target Lesion Revascularization | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Target Vessel Revascularization not involving the Target Lesion | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Target Vessel Revascularization | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Target Vessel Failure | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Major Vascular Complications | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
| Ischemic Complications | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up. |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |