The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01665053
First received: August 7, 2012
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: PROMUS Element Plus
Device: SYNERGY

  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

A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013.

The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.


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 Plus

PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

PROMUS Element Plus: A drug eluting coronary stent system

SYNERGY

SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

SYNERGY: A drug eluting coronary stent system


Participant Flow:   Overall Study
    Promus Element Plus     SYNERGY  
STARTED     838     846  
Completed 12-Month Clinical F/U     797     822  
No 12-Month F/U     32     15  
Death With No 12-month Clinical FU     9     9  
COMPLETED     806     831  
NOT COMPLETED     32     15  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Promus Element Plus

PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

PROMUS Element Plus: A drug eluting coronary stent system

SYNERGY

SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

SYNERGY: A drug eluting coronary stent system

Total Total of all reporting groups

Baseline Measures
    Promus Element Plus     SYNERGY     Total  
Number of Participants  
[units: participants]
  838     846     1684  
Age  
[units: yr]
Mean (Standard Deviation)
  63.92  (10.50)     63.48  (10.44)     63.70  (10.47)  
Gender  
[units: participants]
     
Female     229     249     478  
Male     609     597     1206  
Race/Ethnicity, Customized [1]
[units: participants]
     
American Indian or Alaska native     2     1     3  
Asian     100     100     200  
Black,of African heritage     37     52     89  
Caucasian     664     655     1319  
Hispanic or Latino     16     15     31  
Native Hawaiian or other Pacific Islander     2     3     5  
Other     5     4     9  
Not Disclosed     13     20     33  
Region of Enrollment  
[units: participants]
     
Singapore     12     15     27  
United States     506     514     1020  
Japan     81     74     155  
Spain     20     18     38  
New Zealand     13     11     24  
Canada     56     58     114  
Latvia     12     11     23  
Netherlands     13     12     25  
Austria     2     1     3  
Belgium     50     50     100  
Finland     14     16     30  
Denmark     9     10     19  
Poland     4     5     9  
Italy     10     11     21  
Australia     16     17     33  
France     20     23     43  
Height  
[units: inches]
Mean (Standard Deviation)
  67.44  (4.07)     67.23  (4.00)     67.33  (4.04)  
Weight  
[units: lbs]
Mean (Standard Deviation)
  190.45  (44.29)     190.92  (44.09)     190.69  (44.18)  
Smoking  
[units: participants]
     
Smoking, Ever     519     510     1029  
Smoking,Unknown     12     19     31  
Smoking, Never     307     317     624  
Current Diabetes Mellitus  
[units: participants]
     
Current Diabetes Mellitus     276     275     551  
No Current Diabetes Mellitus     562     571     1133  
Hyperlipidemia Requiring Medication  
[units: participants]
     
Hyperlipidemia Requiring Medication     621     625     1246  
No Hyperlipidemia requiring Medication     217     221     438  
Hypertension Requiring Medication  
[units: participants]
     
Hypertension requiring medication     629     652     1281  
No Hypertension requiring medication     209     194     403  
History of bleeding disorder  
[units: participants]
     
Hystory of bleeding disorder     1     2     3  
No history of bleeding disorder     837     844     1681  
History of GI bleeding  
[units: participants]
     
History of GI Bleeding     0     2     2  
No History of GI Bleeding     838     844     1682  
History of Transient Ischemic Attack  
[units: participants]
     
History of Transient Ischemic Attack     23     24     47  
No History of Transient Ischemic Attack     815     822     1637  
History of cerebrovascular accident  
[units: participants]
     
History of Cerebrovascular Accident     32     30     62  
No History of Cerebrovascular Accident     806     816     1622  
History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA)  
[units: participants]
     
History of TIA or CVA     49     48     97  
No history of TIA or CVA     789     798     1587  
History of peripheral vascular disease (PVD)  
[units: participants]
     
History of PVD     59     68     127  
No History of PVD     779     778     1557  
History of renal disease  
[units: participants]
     
History of renal disease     52     56     108  
No History of renal disease     786     790     1576  
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set [2]
[units: Number of lesions]
     
Left Anterior Descending (LAD)     433     437     870  
Left Circumflex Artery (LCx)     275     265     540  
Right Coronary Artery (RCA)     334     357     691  
Left Main Coronary Artery (LMCA)     1     0     1  
[1]

The Ethnicity and Race data are not mutually exclusive. For example: subject can check both “Asian” and “Native Hawaiian or other Pacific Islander”, or “Caucasian” and “Hispanic or Latino”.

Therefore the sum of participants in all Categories for the Measure does not equal the Overall Number of Baseline Participants in the Arm/Group

[2]

The Promus Element Plus group has 1043 lesions in 838 subjects enrolled in this treatment arm.

The Synergy group has 1059 lesions in 846 subjects enrolled in this treatment arm.

The measure type is number of lesions. The total number of lesions does not match with the total number of participants since some of the participants have more than one lesion.




  Outcome Measures
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1.  Primary:   Percentage of Participants With Target Lesion Failure (TLF) at 12 Months   [ Time Frame: 12 months ]

2.  Secondary:   Target Lesion Revascularization (TLR) Rate   [ Time Frame: 12 months ]

3.  Secondary:   Target Vessel Revascularization (TVR) Rate   [ Time Frame: 12 months ]

4.  Secondary:   Target Vessel Failure (TVF) Rate   [ Time Frame: 12 months ]

5.  Secondary:   Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate   [ Time Frame: 12 months ]

6.  Secondary:   Cardiac Death Rate   [ Time Frame: 12 months ]

7.  Secondary:   Non-Cardiac Death Rate   [ Time Frame: 12 months ]

8.  Secondary:   All Death Rate   [ Time Frame: 12 months ]

9.  Secondary:   Cardiac Death or Myocardial Infarction (MI) Rate   [ Time Frame: 12 months ]

10.  Secondary:   All Death or Myocardial Infarction (MI) Rate   [ Time Frame: 12 months ]

11.  Secondary:   All Death, Myocardial Infarction (MI) or Target Vessel Revascularization (TVR) Rate   [ Time Frame: 12 months ]

12.  Secondary:   Stent Thrombosis Rate by Academic Research Consortium (ARC) Definition   [ Time Frame: 12 months ]

13.  Secondary:   Stroke Rate (Ischemic, Hemorrhagic and Undetermined)   [ Time Frame: 12 months ]

14.  Secondary:   Technical Success Rate   [ Time Frame: Day 1 (periprocedure) ]

15.  Secondary:   Clinical Procedural Success Rate   [ Time Frame: Day 1 (periprocedure) ]

16.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 12 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: LORIN PETRE, Clinical Trial Manager
Organization: Boston Scientific
phone: +(32)473930176
e-mail: lorin.petre@bsci.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01665053     History of Changes
Other Study ID Numbers: S2067
G120123 ( Other Identifier: FDA )
Study First Received: August 7, 2012
Results First Received: December 1, 2015
Last Updated: February 18, 2016
Health Authority: United States: Food and Drug Administration