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The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.
This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYPHER Sirolimus-eluting Coronary Stent | Device | 2.25 Cypher Sirolimus-eluting Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure | In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram. | From post-procedure to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up | The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Iyer, MD | Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17126649 | Background | Moses JW, Nikolsky E, Mehran R, Cambier PA, Bachinsky WB, Leya F, Kuntz RE, Popma JJ, Schleckser P, Wang H, Cohen SA, Leon MB; SIRIUS 2.25 Investigators. Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. Am J Cardiol. 2006 Dec 1;98(11):1455-60. doi: 10.1016/j.amjcard.2006.06.047. Epub 2006 Oct 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent | The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent | The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions |
| 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 Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure | In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram. | The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 6 months |
|
From post-procedure to 1440 days follow up
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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 | 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent | The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Systematic Assessment | Total number of participants who died from post-procedure to 1440 days 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 participants who had sufficient 4 years 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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| From post-procedure to 4 years |
| Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure. | In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram. | From post-procedure to 6 months |
| Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure. | From post-procedure to 6 months |
| Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure. | TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. | From post-procedure to 6 months and 9 months |
| Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure. | TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA. | From post-procedure to 6 months and 9 months follow-up |
| Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure | TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. | From post-procedure to 6 months and 9 months follow-up |
| Average Lumen Volume (mm3) at Post-procedure | At Post-procedure |
| Average Stent Obstruction Volume at Post-procedure | Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected | At post-procedure |
| Average Lumen Volume (mm3) at 6 Months Post-procedure | From post-procedure to 6 months |
| Average Stent Obstruction Volume at 6 Months Post-procedure | From post-procedure to 6 months |
| Percentage of Participants Who Achieved Lesion Success at Post-procedure | Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method | At post-procedure |
| Percentage of Participants Who Achieved Device Success at Post-procedure | Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used | At post-procedure |
| Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge | Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay | From post-procedure to hospital discharge |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes Mellitus | Number | participants |
|
| History of Myocardial Infarction (MI) | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up | The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. 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). | The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 4 years |
|
|
|
| Secondary | Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure. | In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram. | The number of participants with six months follow up and non-missing six months binary angiographic restenosis results. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 6 months |
|
|
|
| Secondary | Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure. | The number of participants with six months follow up and non-missing six months binary angiographic restenosis results. | Posted | Mean | Standard Deviation | mm | From post-procedure to 6 months |
|
|
|
| Secondary | Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure. | TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. | The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 6 months and 9 months |
|
|
|
| Secondary | Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure. | TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA. | The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 6 months and 9 months follow-up |
|
|
|
| Secondary | Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure | TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. | The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to 6 months and 9 months follow-up |
|
|
|
| Secondary | Average Lumen Volume (mm3) at Post-procedure | The number of participants who had lumen volume data at post-procedure | Posted | Mean | Standard Deviation | mm3 | At Post-procedure |
|
|
|
| Secondary | Average Stent Obstruction Volume at Post-procedure | Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected | Number of participants who had Stent Obstruction Volume data at post-procedure | Posted | Mean | Standard Deviation | mm3 | At post-procedure |
|
|
|
| Secondary | Average Lumen Volume (mm3) at 6 Months Post-procedure | The number of participants who had Lumen Volume data at 6 months post-procedure | Posted | Mean | Standard Deviation | mm3 | From post-procedure to 6 months |
|
|
|
| Secondary | Average Stent Obstruction Volume at 6 Months Post-procedure | The number of participants with Stent Obstruction Volume data at 6 months post-procedure | Posted | Mean | Standard Deviation | mm3 | From post-procedure to 6 months |
|
|
|
| Secondary | Percentage of Participants Who Achieved Lesion Success at Post-procedure | Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method | Number of Participants without missing lesion success data | Posted | Mean | 95% Confidence Interval | Percentage of participants | At post-procedure |
|
|
|
| Secondary | Percentage of Participants Who Achieved Device Success at Post-procedure | Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used | All participants | Posted | Mean | 95% Confidence Interval | Percentage of participants | At post-procedure |
|
|
|
| Secondary | Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge | Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay | Number of participants without missing procedure success data | Posted | Mean | 95% Confidence Interval | Percentage of participants | From post-procedure to hospital discharge |
|
|
|
| 5 |
| 91 |
| 39 |
| 96 |
|
|
| Target Lesion Revascularization | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Target Vessel Revascularization not involving Target Lesion | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Target Vessel Revascularization (All) | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Acute/Subacute Stent Thrombosis to 30 Days | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Late Stent Thrombosis (31-1440 Days) | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Subacute Closure | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Cerebrovascular Accident (CVA) | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years post-procedure follow-up or who had at least one event prior to the end of follow-up |
|
| Hemorrhagic Vascular Complications | Vascular disorders | Non-systematic Assessment | The number at risk is defined as the number of participants who had sufficient 4 years 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 participants who had sufficient 4 years 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 |
|
| 2 Years Post-Procedure |
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| 3 Years Post-Procedure |
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| 4 Years Post-Procedure |
|