Trial Outcomes & Findings for Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions (NCT NCT00232739)
NCT ID: NCT00232739
Last Updated: 2010-03-16
Results Overview
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.
COMPLETED
PHASE3
100 participants
From post-procedure to 6 months
2010-03-16
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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100
|
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Overall Study
COMPLETED
|
91
|
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Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Baseline characteristics by cohort
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=100 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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48 Participants
n=99 Participants
|
|
Age Continuous
|
63.4 years
STANDARD_DEVIATION 9.90 • n=99 Participants
|
|
Sex: Female, Male
Female
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36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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64 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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100 participants
n=99 Participants
|
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Diabetes Mellitus
Diabetes Mellitus
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40 participants
n=99 Participants
|
|
Diabetes Mellitus
Without Diabetes Mellitus
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60 participants
n=99 Participants
|
|
History of Myocardial Infarction (MI)
History of MI
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33 participants
n=99 Participants
|
|
History of Myocardial Infarction (MI)
Without History of MI
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61 participants
n=99 Participants
|
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History of Myocardial Infarction (MI)
N/A
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6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From post-procedure to 6 monthsPopulation: The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.
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.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=77 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
|
16.9 Percentage of participants
Interval 9.3 to 27.1
|
SECONDARY outcome
Timeframe: From post-procedure to 4 yearsPopulation: 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.
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).
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=96 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
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Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
6 Months Post-Procedure
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8.0 Percentage of participants
Interval 2.7 to 13.3
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|
Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
9 Months Post-Procedure
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9.0 Percentage of participants
Interval 3.3 to 14.7
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Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
12 Months Post-Procedure
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11.0 Percentage of participants
Interval 4.9 to 17.1
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Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
2 Years Post-Procedure
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17.0 Percentage of participants
Interval 9.6 to 24.4
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Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
3 Years Post-Procedure
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21.0 Percentage of participants
Interval 13.0 to 29.0
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Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
4 Years Post-Procedure
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27.4 Percentage of participants
Interval 18.2 to 36.6
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SECONDARY outcome
Timeframe: From post-procedure to 6 monthsPopulation: The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.
In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=77 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.
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11.7 Percentage of participants
Interval 5.5 to 21.0
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SECONDARY outcome
Timeframe: From post-procedure to 6 monthsPopulation: The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=77 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
Average In-stent MLD
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1.64 mm
Standard Deviation 0.52
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Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
Average In-lesion MLD
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1.35 mm
Standard Deviation 0.45
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SECONDARY outcome
Timeframe: From post-procedure to 6 months and 9 monthsPopulation: The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.
TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=95 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
6 Months Post-Procedure
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5.1 Percentage of participants
Interval 0.8 to 9.4
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|
Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
9 Months Post-Procedure
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6.1 Percentage of participants
Interval 1.2 to 11.0
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SECONDARY outcome
Timeframe: From post-procedure to 6 months and 9 months follow-upPopulation: The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.
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.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=95 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
6 Months Post-Procedure
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8.1 Percentage of participants
Interval 2.8 to 13.4
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Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
9 Months Post-Procedure
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10.1 Percentage of participants
Interval 4.2 to 16.0
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SECONDARY outcome
Timeframe: From post-procedure to 6 months and 9 months follow-upPopulation: The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.
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.
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=96 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
6 Months Post-Procedure
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11.0 Percentage of participants
Interval 4.9 to 17.1
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Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
9 Months Post-Procedure
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13.0 Percentage of participants
Interval 6.3 to 19.7
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SECONDARY outcome
Timeframe: At Post-procedurePopulation: The number of participants who had lumen volume data at post-procedure
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=11 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Average Lumen Volume (mm3) at Post-procedure
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73.34 mm3
Standard Deviation 38.32
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SECONDARY outcome
Timeframe: At post-procedurePopulation: Number of participants who had Stent Obstruction Volume data 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
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=11 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Average Stent Obstruction Volume at Post-procedure
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0.0 mm3
Standard Deviation 0.0
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SECONDARY outcome
Timeframe: From post-procedure to 6 monthsPopulation: The number of participants who had Lumen Volume data at 6 months post-procedure
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=8 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
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Average Lumen Volume (mm3) at 6 Months Post-procedure
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70.25 mm3
Standard Deviation 25.61
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SECONDARY outcome
Timeframe: From post-procedure to 6 monthsPopulation: The number of participants with Stent Obstruction Volume data at 6 months post-procedure
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=8 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Average Stent Obstruction Volume at 6 Months Post-procedure
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3.05 mm3
Standard Deviation 2.42
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SECONDARY outcome
Timeframe: At post-procedurePopulation: Number of Participants without missing lesion success data
Lesion success defined as the attainment of \<50 percent residual stenosis (by QCA) using any percutaneous method
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=99 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Percentage of Participants Who Achieved Lesion Success at Post-procedure
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98.0 Percentage of participants
Interval 92.9 to 99.8
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SECONDARY outcome
Timeframe: At post-procedurePopulation: All participants
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
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=100 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Percentage of Participants Who Achieved Device Success at Post-procedure
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96.0 Percentage of participants
Interval 90.1 to 98.9
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SECONDARY outcome
Timeframe: From post-procedure to hospital dischargePopulation: Number of participants without missing procedure success data
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
Outcome measures
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=99 Participants
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
|
|---|---|
|
Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge
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97.0 Percentage of participants
Interval 91.4 to 99.4
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Adverse Events
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Serious adverse events
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=96 participants at risk；n=91 participants at risk
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
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|---|---|
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Vascular disorders
Death
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5.5%
5/91 • Number of events 5 • From post-procedure to 1440 days follow up
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Other adverse events
| Measure |
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
n=96 participants at risk；n=91 participants at risk
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
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|---|---|
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Vascular disorders
Myocardial Infarction (Q wave or Non-Q wave)
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14.9%
14/94 • Number of events 14 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Target Lesion Revascularization
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14.7%
14/95 • Number of events 14 • From post-procedure to 1440 days follow up
|
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Vascular disorders
Target Vessel Revascularization not involving Target Lesion
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8.7%
8/92 • Number of events 8 • From post-procedure to 1440 days follow up
|
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Vascular disorders
Target Vessel Revascularization (All)
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21.1%
20/95 • Number of events 20 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Acute/Subacute Stent Thrombosis to 30 Days
|
1.1%
1/92 • Number of events 1 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Late Stent Thrombosis (31-1440 Days)
|
4.4%
4/91 • Number of events 4 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Subacute Closure
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1.1%
1/92 • Number of events 1 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Cerebrovascular Accident (CVA)
|
4.3%
4/92 • Number of events 4 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Hemorrhagic Vascular Complications
|
6.5%
6/92 • Number of events 6 • From post-procedure to 1440 days follow up
|
|
Vascular disorders
Target Vessel Failure
|
27.1%
26/96 • Number of events 26 • From post-procedure to 1440 days follow up
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60