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A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) (PLATINUM QCA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00824434
First received: January 15, 2009
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
Results First Received: December 20, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atherosclerosis
Coronary Artery Disease
Intervention: Device: PROMUS Element™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of 100 subjects was planned, 100 were enrolled at 14 investigative sites in the Asia Pacific region by July 22, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PROMUS Element Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)

Participant Flow:   Overall Study
    PROMUS Element  
STARTED     100  
COMPLETED     100  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
PROMUS Element Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)

Baseline Measures
    PROMUS Element  
Number of Participants  
[units: participants]
 		  100  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     60  
>=65 years     40  
Age  
[units: years]
Mean ± Standard Deviation 		  61.82  ± 9.92  
Gender  
[units: participants]
 		 
Female     23  
Male     77  
Race/Ethnicity, Customized [1]
[units: Participant]
 		 
Asian     16  
Caucasian     78  
Maori     1  
Native Hawaiian or other Pacific Islander     2  
Other     3  
Region of Enrollment  
[units: participants]
 		 
Malaysia     9  
Singapore     3  
Australia     49  
New Zealand     39  
General Medical History [1]
[units: Participant]
 		 
Smoking, Ever     64  
Medically Treated Diabetes     19  
Hyperlipidemia Requiring Medication     81  
Hypertension Requiring. Medication     66  
History of Bleeding Disorder     3  
Cardiac History [1]
[units: Participant]
 		 
Stable Angina     57  
Unstable Angina     38  
No Angina     5  
Silent Ischemia     2  
Family History of Coronary Artery Disease     49  
Previous MI     39  
History of Percutaneous Coronary Intervention     31  
History of Coronary Artery Bypass Graft     5  
History of Arrhythmia     4  
History of Multivessel Disease     34  
History of Left Main Disease     2  
Cardiac History-Left Ventricular Ejection Fraction  
[units: Percent ejection fraction]
Mean ± Standard Deviation 		  64.41  ± 13.30  
Neurologic History [1]
[units: Participant]
 		 
History of Transient Ischemic Attack     2  
History of Cerebrovascular Accident     3  
Renal and Peripheral History [1]
[units: Participant]
 		 
History of Renal Disease     1  
History of Peripheral Vascular Disease     3  
Lesion Characteristic-Target Vessel  
[units: Lesion]
 		 
Left Anterior Descending Artery     35  
Left Circumflex Artery     30  
Right Coronary Artery     35  
Lesion Location  
[units: Lesions]
 		 
Proximal     37  
Mid     54  
Distal     7  
Ostial     2  
Lesion Characteristics  
[units: millimeters]
Mean ± Standard Deviation 		 
Reference Vessel Diameter     2.72  ± 0.53  
Minimum Lumen Diameter     0.71  ± 0.34  
Lesion Length     15.40  ± 7.03  
Lesion Characteristic-Diameter Stenosis  
[units: Percent Diameter Stenosis]
Mean ± Standard Deviation 		  74.09  ± 10.93  
Lesion Characteristics [2]
[units: Lesions]
 		 
Eccentric Lesion     53  
Bend >45%     12  
Tortuosity     9  
Calcification, any     18  
Total Occlusion     1  
Branch Vessel Disease     6  
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class [3]
[units: Lesions]
 		 
A     5  
B1     28  
B2     42  
C     25  
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [4]
[units: Lesion]
 		 
0     1  
1     0  
2     1  
3     98  
[1] The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
[2] The same lesion may be included in more than one category therefore the number of lesions for this baseline measure does not equal the total number of lesions or participants in the group.
[3]

Type A lesions: minimally complex, readily accessible, non-angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, and an absence of thrombus.

Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus.

Type C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.
[4] TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiac Events (Composite)   [ Time Frame: 30 days ]
  Show Outcome Measure 1

2.  Secondary:   In-stent Late Loss   [ Time Frame: 9 months ]
  Show Outcome Measure 2

3.  Secondary:   Occurance of Post-procedure Incomplete Stent Apposition   [ Time Frame: Post-procedure ]
  Show Outcome Measure 3

4.  Secondary:   Myocardial Infarction (MI)   [ Time Frame: 12 months ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Myocardial Infarction (MI)
Measure Description New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame 12 months  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Reporting Groups
  Description
PROMUS Element Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)

Measured Values
    PROMUS Element  
Number of Participants Analyzed  
[units: participants]
 		  100  
Myocardial Infarction (MI)  
[units: percentage of participants]
 		  0.0  

No statistical analysis provided for Myocardial Infarction (MI)



5.  Secondary:   All-cause Mortality   [ Time Frame: 12 months ]
  Show Outcome Measure 5

6.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 30 Days ]
  Show Outcome Measure 6

7.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 12 Months ]
  Show Outcome Measure 7

8.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 30 Days ]
  Show Outcome Measure 8

9.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 12 months ]
  Show Outcome Measure 9

10.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 12 months ]
  Show Outcome Measure 10

11.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 12 months ]
  Show Outcome Measure 11

12.  Secondary:   Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition   [ Time Frame: 24 hours ]
  Show Outcome Measure 12

13.  Secondary:   Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition   [ Time Frame: >24 hr-30 days ]
  Show Outcome Measure 13

14.  Secondary:   Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition   [ Time Frame: >30 days-1 year ]
  Show Outcome Measure 14

15.  Secondary:   Clinical Procedural Success   [ Time Frame: Duration of hospital stay (usually 1-2 days) ]
  Show Outcome Measure 15

16.  Secondary:   Technical Success   [ Time Frame: Acute-At time of index procedure ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ruth Starzyk, PhD
Organization: Boston Scientific
phone: 508-683-6577
e-mail: ruth.starzyk@bsci.com


Publications of Results:


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00824434     History of Changes
Other Study ID Numbers: S2051
Study First Received: January 15, 2009
Results First Received: December 20, 2011
Last Updated: August 17, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Institutional Review Board
Singapore: Health Sciences Authority