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Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

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ClinicalTrials.gov Identifier: NCT00232739
Recruitment Status : Completed
First Posted : October 5, 2005
Results First Posted : February 8, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Cordis Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Device: CYPHER Sirolimus-eluting Coronary Stent
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Period Title: Overall Study
Started 100
Completed 91
Not Completed 9
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
52
  52.0%
>=65 years
48
  48.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
63.4  (9.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
36
  36.0%
Male
64
  64.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Diabetes Mellitus 40
Without Diabetes Mellitus 60
History of Myocardial Infarction (MI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
History of MI 33
Without History of MI 61
N/A 6
1.Primary Outcome
Title Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
Hide Description 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.
Time Frame From post-procedure to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 77
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
16.9
(9.3 to 27.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Comments Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.
Method Bayesian regression model
Comments Multi-level Bayesian regression model was used in the secondary analysis
Method of Estimation Estimation Parameter Primary analysis posterior probability
Estimated Value 0.9926
Estimation Comments Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.
2.Secondary Outcome
Title Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
Hide Description 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).
Time Frame From post-procedure to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 96
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
6 Months Post-Procedure
8.0
(2.7 to 13.3)
9 Months Post-Procedure
9.0
(3.3 to 14.7)
12 Months Post-Procedure
11.0
(4.9 to 17.1)
2 Years Post-Procedure
17.0
(9.6 to 24.4)
3 Years Post-Procedure
21.0
(13.0 to 29.0)
4 Years Post-Procedure
27.4
(18.2 to 36.6)
3.Secondary Outcome
Title Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.
Hide Description In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.
Time Frame From post-procedure to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 77
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
11.7
(5.5 to 21.0)
4.Secondary Outcome
Title Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
Hide Description [Not Specified]
Time Frame From post-procedure to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: mm
Average In-stent MLD 1.64  (0.52)
Average In-lesion MLD 1.35  (0.45)
5.Secondary Outcome
Title Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
Hide Description TLR was defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.
Time Frame From post-procedure to 6 months and 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 95
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
6 Months Post-Procedure
5.1
(0.8 to 9.4)
9 Months Post-Procedure
6.1
(1.2 to 11.0)
6.Secondary Outcome
Title Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
Hide Description 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.
Time Frame From post-procedure to 6 months and 9 months follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 95
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
6 Months Post-Procedure
8.1
(2.8 to 13.4)
9 Months Post-Procedure
10.1
(4.2 to 16.0)
7.Secondary Outcome
Title Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
Hide Description 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.
Time Frame From post-procedure to 6 months and 9 months follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 96
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
6 Months Post-Procedure
11.0
(4.9 to 17.1)
9 Months Post-Procedure
13.0
(6.3 to 19.7)
8.Secondary Outcome
Title Average Lumen Volume (mm3) at Post-procedure
Hide Description [Not Specified]
Time Frame At Post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who had lumen volume data at post-procedure
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm3
73.34  (38.32)
9.Secondary Outcome
Title Average Stent Obstruction Volume at Post-procedure
Hide Description 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
Time Frame At post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants who had Stent Obstruction Volume data at post-procedure
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm3
0.0  (0.0)
10.Secondary Outcome
Title Average Lumen Volume (mm3) at 6 Months Post-procedure
Hide Description [Not Specified]
Time Frame From post-procedure to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who had Lumen Volume data at 6 months post-procedure
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mm3
70.25  (25.61)
11.Secondary Outcome
Title Average Stent Obstruction Volume at 6 Months Post-procedure
Hide Description [Not Specified]
Time Frame From post-procedure to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants with Stent Obstruction Volume data at 6 months post-procedure
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mm3
3.05  (2.42)
12.Secondary Outcome
Title Percentage of Participants Who Achieved Lesion Success at Post-procedure
Hide Description Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method
Time Frame At post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of Participants without missing lesion success data
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 99
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.0
(92.9 to 99.8)
13.Secondary Outcome
Title Percentage of Participants Who Achieved Device Success at Post-procedure
Hide Description 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
Time Frame At post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 100
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.0
(90.1 to 98.9)
14.Secondary Outcome
Title Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge
Hide Description 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
Time Frame From post-procedure to hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants without missing procedure success data
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description:
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
Overall Number of Participants Analyzed 99
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.0
(91.4 to 99.4)
Time Frame From post-procedure to 1440 days follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Hide Arm/Group Description The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
All-Cause Mortality
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Affected / at Risk (%) # Events
Total   5/91 (5.49%)    
Vascular disorders   
Death  [1]  5/91 (5.49%)  5
Indicates events were collected by systematic assessment
[1]
Total number of participants who died from post-procedure to 1440 days follow up.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Affected / at Risk (%) # Events
Total   39/96 (40.63%)    
Vascular disorders   
Myocardial Infarction (Q wave or Non-Q wave) * [1]  14/94 (14.89%)  14
Target Lesion Revascularization * [1]  14/95 (14.74%)  14
Target Vessel Revascularization not involving Target Lesion * [1]  8/92 (8.70%)  8
Target Vessel Revascularization (All) * [1]  20/95 (21.05%)  20
Acute/Subacute Stent Thrombosis to 30 Days * [1]  1/92 (1.09%)  1
Late Stent Thrombosis (31-1440 Days) * [1]  4/91 (4.40%)  4
Subacute Closure * [1]  1/92 (1.09%)  1
Cerebrovascular Accident (CVA) * [1]  4/92 (4.35%)  4
Hemorrhagic Vascular Complications * [1]  6/92 (6.52%)  6
Target Vessel Failure * [1]  26/96 (27.08%)  26
*
Indicates events were collected by non-systematic assessment
[1]
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sidney Cohen, MD PhD, Vice President
Organization: Cordis
Phone: 650 614-2726
Responsible Party: Sriram Iyer, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00232739     History of Changes
Other Study ID Numbers: P03-6320
First Submitted: October 3, 2005
First Posted: October 5, 2005
Results First Submitted: October 19, 2009
Results First Posted: February 8, 2010
Last Update Posted: March 16, 2010