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Trial record 85 of 292 for:    ASPIRIN AND clopidogrel AND dual

CYPRESS - CYPHER for Evaluating Sustained Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00954707
Recruitment Status : Unknown
Verified January 2014 by Cordis Corporation.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2009
Results First Posted : October 9, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin
Drug: Placebo & Aspirin
Enrollment 2509
Recruitment Details A total of 2509 patients were enrolled from August 28, 2009 to January 14, 2011 across 139 clinical sites in the Unites States.
Pre-assignment Details During the Phase I of this study, enrolled subjects were treated with at least one CYPHER® stent plus thienopyridine treatment and aspirin. During Phase II, approximately 1500 eligible subjects were randomized to either placebo or thienopyridine treatment. It is estimated that the Phase II results will be available for publishing by July 31, 2014.
Arm/Group Title All Enrolled Subjects
Hide Arm/Group Description Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
Period Title: Overall Study
Started 2509
Completed 2342 [1]
Not Completed 167
Reason Not Completed
Death             34
Withdrawal by Subject             100
Lost to Follow-up             33
[1]
2342 Subjects completed 12-month Phase 1 follow-up; 167 subjects didn't complete the Phase 1.
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Baseline Participants 2509
Hide Baseline Analysis Population Description
Enrolled subjects were those who signed the informed consent and had met all of the inclusion and none of the exclusion criteria, and the target lesion had been successfully crossed with the intracoronary guidewire which was positioned intraluminally in the distal vessel. Enrolled subjects were also Intent to Treat (ITT).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2509 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1368
  54.5%
>=65 years
1141
  45.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2509 participants
63.26  (10.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2509 participants
Female
785
  31.3%
Male
1724
  68.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2509 participants
Hispanic or Latino
132
   5.3%
Not Hispanic or Latino
2293
  91.4%
Unknown or Not Reported
84
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2509 participants
American Indian or Alaska Native
6
   0.2%
Asian
37
   1.5%
Native Hawaiian or Other Pacific Islander
6
   0.2%
Black or African American
185
   7.4%
White
2225
  88.7%
More than one race
0
   0.0%
Unknown or Not Reported
50
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2509 participants
2509
1.Primary Outcome
Title Phase I: the Rate of Target Lesion Failure (TLF)
Hide Description Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Active subjects in the ITT population at 12-month post procedure
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2322
Measure Type: Number
Unit of Measure: participants
149
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of TLF at 12-month (%)
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
5.5 to 7.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate of Device Success
Hide Description A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Time Frame From post- procedure to hospital discharge, up to 39 days
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of devices the Intent-to-Treat patients used in the study.
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2509
Overall Number of Units Analyzed
Type of Units Analyzed: Devices
3271
Measure Type: Number
Unit of Measure: Devices
3205
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of device success (%)
Estimated Value 98.0
Confidence Interval (2-Sided) 95%
97.4 to 98.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Lesion Success
Hide Description Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.
Time Frame From post- procedure to hospital discharge, up to 39 days
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of lesions the Intent-to-Treat population had at the beginning of the study
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2509
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
3271
Measure Type: Number
Unit of Measure: Lesions
3264
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of lesion success (%)
Estimated Value 99.8
Confidence Interval (2-Sided) 95%
99.6 to 99.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Rate of Procedure Success
Hide Description Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.
Time Frame From post- procedure to hospital discharge, up to 39 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2509
Measure Type: Number
Unit of Measure: participants
2444
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of procedure success (%)
Estimated Value 97.7
Confidence Interval (2-Sided) 95%
97.0 to 98.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Rate of Clinically-driven Target Lesion Revascularization (TVR)
Hide Description Defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject 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 ≥50% by QCA.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2318
Measure Type: Number
Unit of Measure: participants
98
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of Clinically-driven TLR (%)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
3.45 to 5.13
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Rate of Clinically Driven Target Vessel Revascularization (TVR)
Hide Description Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject 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 ≥50% by QCA.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2318
Measure Type: Number
Unit of Measure: participants
124
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of Clinically-driven TVR (%)
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
4.87 to 6.81
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Rate of Target Vessel Failure (TVF)
Hide Description Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2323
Measure Type: Number
Unit of Measure: participants
184
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of Target vessel failure (%)
Estimated Value 7.92
Confidence Interval (2-Sided) 95%
6.85 to 9.09
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Rate of Major Adverse Cardiac Events (MACE)
Hide Description MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2322
Measure Type: Number
Unit of Measure: participants
172
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of MACE (%)
Estimated Value 7.41
Confidence Interval (2-Sided) 95%
6.37 to 8.55
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Rate of Protocol Defined Stent Thrombosis (ST)
Hide Description Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2313
Measure Type: Number
Unit of Measure: participants
21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of protocol defined ST (%)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.56 to 1.38
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
Hide Description ARC defined ST classifies ST by type – definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2313
Measure Type: Number
Unit of Measure: participants
26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of ARC defined ST (%)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.74 to 1.64
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Rate of Protocol Defined Major Bleeding Complications
Hide Description Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2314
Measure Type: Number
Unit of Measure: participants
71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of major bleeding complications (%)
Estimated Value 3.07
Confidence Interval (2-Sided) 95%
2.40 to 3.85
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Rate of Cardiac Death
Hide Description Include all deaths due to cardiac causes.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2313
Measure Type: Number
Unit of Measure: participants
18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of cardiac death (%)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.46 to 1.23
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Rate of Non-cardiac Death
Hide Description Include all deaths due to non-cardiac causes.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description:
The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
Overall Number of Participants Analyzed 2313
Measure Type: Number
Unit of Measure: participants
16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYPHER® Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of non-cardiac death (%)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.40 to 1.12
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CYPHER® Stent
Hide Arm/Group Description The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and "closed cell" architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion.
All-Cause Mortality
CYPHER® Stent
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CYPHER® Stent
Affected / at Risk (%) # Events
Total   34/2509 (1.36%)    
Cardiac disorders   
Cardiac Death   18/2509 (0.72%)  18
General disorders   
Non-cardiac death   16/2509 (0.64%)  16
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CYPHER® Stent
Affected / at Risk (%) # Events
Total   414/2509 (16.50%)    
Cardiac disorders   
Angina pectoris  1  108/2509 (4.30%)  150
Angina unstable   53/2509 (2.11%)  77
Coronary artery disease   43/2509 (1.71%)  64
Coronary artery occlusion   31/2509 (1.24%)  34
Myocardial infarction   76/2509 (3.03%)  99
Coronary artery dissection   79/2509 (3.15%)  80
General disorders   
Catheter site haematoma   39/2509 (1.55%)  40
Injury, poisoning and procedural complications   
In-stent coronary artery restenosis   28/2509 (1.12%)  46
Investigations   
Cardiac enzymes increased   26/2509 (1.04%)  28
Respiratory, thoracic and mediastinal disorders   
Epistaxis   27/2509 (1.08%)  30
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: Amy Orlick, Associate Director
Organization: Cordis Corporation, a Johnson & Johnson company
Phone: 908-541-4347
Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00954707     History of Changes
Other Study ID Numbers: P09-6301
First Submitted: August 6, 2009
First Posted: August 7, 2009
Results First Submitted: April 26, 2013
Results First Posted: October 9, 2013
Last Update Posted: February 7, 2014