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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: October 11, 2016
Last verified: October 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
Overall Participants Analyzed 
[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 
[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

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 [1] 
[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 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
  Show All Outcome Measures

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

2.  Secondary:   Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.   [ Time Frame: 12 months ]

3.  Secondary:   Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.   [ Time Frame: 12 months ]

4.  Secondary:   Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.   [ Time Frame: 12 months ]

5.  Secondary:   Percentage of Participants With Myocardial Infarction at 12 Month.   [ Time Frame: 12 months ]

6.  Secondary:   Percentage of Participants With Cardiac Death at 12 Month.   [ Time Frame: 12 months ]

7.  Secondary:   Percentage of Participants With Non-Cardiac Death at 12 Month.   [ Time Frame: 12 months ]

8.  Secondary:   Percentage of Patients That Died at 12 Months.   [ Time Frame: 12 months ]

9.  Secondary:   Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.   [ Time Frame: 12 months ]

10.  Secondary:   Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.   [ Time Frame: 12 months ]

11.  Secondary:   Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.   [ Time Frame: 12 months ]

12.  Secondary:   Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.   [ Time Frame: 12 months ]

13.  Secondary:   Percentage of Patients With a Stroke at 12 Month.   [ Time Frame: 12 months ]

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

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

16.  Secondary:   Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.   [ Time Frame: 12 month ]

17.  Secondary:   Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.   [ 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: October 11, 2016
Health Authority: United States: Food and Drug Administration