EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) (EVOLVE II QCA)

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Medstar Research Institute
Quintiles, Inc.
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01787799
First received: January 16, 2013
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: January 6, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atherosclerotic Lesion(s)
Intervention: 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 100 subjects were enrolled at 12 centers in Australia, New Zealand, Singapore and Japan between March 25, 2013 and October 15, 2013.

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
SYNERGY Stent System

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)

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


Participant Flow:   Overall Study
    SYNERGY Stent System  
STARTED     100  
COMPLETED     100  
NOT COMPLETED     0  



  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.
Subjects greater than or equal to 18 years of age with symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia. Subjects received the SYNERGY stent system for treatment of atherosclerotic lesion(s) less than or equal to 34mm in length and between 2.25mm and 4.0mm in diameter, both by visual estimate.

Reporting Groups
  Description
SYNERGY Stent System

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)

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


Baseline Measures
    SYNERGY Stent System  
Number of Participants  
[units: participants]
  100  
Age  
[units: years]
Mean (Standard Deviation)
  64.49  (10.21)  
Gender  
[units: participants]
 
Female     20  
Male     80  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     28  
Black, of African Heritage     0  
Caucasian     70  
Hispanic or Latino     0  
Native Hawaiian or other Pacific Islader     0  
Other     2  
Not disclosed     0  
Region of Enrollment  
[units: participants]
 
New Zealand     69  
Singapore     11  
Japan     10  
Australia     10  
Cardiac Risk Factors [1]
[units: participants]
 
Hyperlipidemia Requiring Medication     90  
Hypertension Requiring Medication     71  
Family History of Coronary Artery Disease     57  
History of PCI     33  
History of Myocardial Infarction     18  
Current Diabetes Mellitus; Medically Treated     17  
Lesion Characteristics  
[units: mm]
Mean (Standard Deviation)
 
Reference Vessel Diameter     2.66  (0.46)  
Lesion Length     14.38  (7.49)  
Minimum Lumen Diameter     0.86  (0.28)  
Percent Diameter Stenosis     67.54  (9.59)  
[1] The same participant may be included in more than one category therefore the number of participants does not equal the total number of participants in the group.



  Outcome Measures

1.  Primary:   In-stent Late Loss   [ Time Frame: 9 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Maurer, MPH; Director of Clinical Trials
Organization: Boston Scientific
phone: 508-683-6678
e-mail: peter.maurer@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01787799     History of Changes
Other Study ID Numbers: S2072
Study First Received: January 16, 2013
Results First Received: January 6, 2016
Last Updated: February 18, 2016
Health Authority: Australia: National Health and Medical Research Council
New Zealand: Ministry of Health
Singapore: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency