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: December 1, 2015
Last verified: December 2015
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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: ins]
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: Percentage of participants]
  74.5     74.0     148.5  
Hypertension Requiring Medication  
[units: Percentage of participants]
  75.1     77.3     152.4  
History of bleeding disorder  
[units: Percentage of participants]
  0.1     0.2     0.3  
History of GI bleeding  
[units: Percentage of participants]
  0.0     0.2     0.2  
History of Transient Ischemic Attack  
[units: Percentage of participants]
  2.7     2.9     5.6  
History of cerebrovascular accident  
[units: Percentage of participants]
  3.8     3.6     7.4  
History of transient ischemic attack or cerebrovascular accident  
[units: percentage of participants]
  5.8     5.7     11.5  
History of peripheral vascular disease  
[units: Percentage of participants]
  7.1     8.1     15.2  
History of renal disease  
[units: Percentage of participants]
  6.2     6.6     12.8  
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set [2]
[units: Percentage of lesions]
     
LAD     41.5     41.3     82.8  
LCx     26.4     25.0     51.4  
RCA     32.0     33.7     65.7  
LMCA     0.1     0.0     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.




  Outcome Measures

1.  Primary:   Target Lesion Failure (TLF) Rate   [ Time Frame: 12 months ]

2.  Secondary:   Target Lesion Revascularization (TLR) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Target Lesion Failure (TLF) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Target Vessel Revascularization (TVR) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   All Revascularization Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Target Vessel Failure (TVF) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Cardiac Death Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Non-Cardiac Death Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   All Death Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   Cardiac Death or Myocardial Infarction (MI) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

12.  Secondary:   All Death or Myocardial Infarction (MI) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

13.  Secondary:   All Death, Myocardial Infarction (MI) or Target Vessel Revascularization (TVR) Rate   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

14.  Secondary:   Stent Thrombosis Rate by Academic Research Consortium (ARC) Definition   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

15.  Secondary:   Stroke Rate (Ischemic and Hemorrhagic)   [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

16.  Secondary:   Technical Success Rate   [ Time Frame: Day 1 (periprocedure) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Clinical Procedural Success Rate   [ Time Frame: Day 1 (periprocedure) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

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: December 1, 2015
Health Authority: United States: Food and Drug Administration