Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01635881
First received: May 25, 2012
Last updated: October 14, 2013
Last verified: October 2013
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: Emerge™ 1.20 mm PTCA Dilatation Catheter

  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
Recruitment of subjects for EMERGE study started on July 09, 2012 and completed on December 14, 2012. Subjects were recruited at 3 investigational centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Emerge Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter

Participant Flow:   Overall Study
    Emerge  
STARTED     60  
COMPLETED     60  
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.
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Reporting Groups
  Description
Emerge Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter

Baseline Measures
    Emerge  
Number of Participants  
[units: participants]
  60  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     19  
Age  
[units: years]
Mean ± Standard Deviation
  60.9  ± 10.5  
Gender  
[units: participants]
 
Female     17  
Male     43  
Race/Ethnicity, Customized  
[units: Participants]
 
American Indian or Alaska native     0  
Asian     0  
Black, or African American     3  
White     57  
Hispanic     0  
Native Hawaiian or Other Pacific Islander     0  
Region of Enrollment  
[units: participants]
 
United States     60  
Cardiac History [1]
[units: Participants]
 
Previous Percutaneous Coronary Intervention     37  
Previous Coronary Artery Bypass Graft     11  
Previous Myocardial Infarction     14  
Congestive Heart Failure     2  
Stable Angina     24  
Unstable Angina     25  
Silent Ischemia     7  
Cardiac Risk Factors [2]
[units: Participants]
 
Smoking, Ever     36  
Medically Treated Diabetes     21  
Hyperlipidemia Requiring Medication     51  
Hypertension Requiring Medication     56  
Family History of Coronary Artery Disease     37  
Lesion Characteristic: Target Lesion Vessel [3]
[units: Lesions]
 
Left Anterior Descending Artery     26  
Circumflex Artery     14  
Right Coronary Artery     21  
Left Main Coronary Artery     1  
Graft     2  
Lesion Characteristic: Lesion Location [3]
[units: Lesions]
 
Ostial     11  
Proximal     16  
Mid     32  
Distal     8  
Lesion Characteristic: Lesion Length [3]
[units: Lesions]
 
Less than 18 mm     51  
From 18 and less than 26 mm     11  
Greater or equal to 26 mm     5  
Lesion Characteristics [3]
[units: Lesions]
 
Thrombus     0  
Tortuosity, Any     9  
Calcification, Any     30  
Ulcerated     0  
Aneurysm     3  
Intimal Flap     0  
Total Occlusion     7  
Eccentric Lesion     40  
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow [3]
[units: Lesions]
 
0 (no perfusion)     5  
1 (penetration with minimal perfusion)     2  
2 (partial perfusion)     1  
3 (complete perfusion)     59  
Lesion Characteristics [3]
[units: Millimeters]
Mean ± Standard Deviation
 
Reference Vessel Diameter     2.6  ± 0.5  
Minimum Lumen Diameter     0.7  ± 0.4  
Lesion Length     15.5  ± 14.7  
Lesion Characteristic: Percent Diameter Stenosis [3]
[units: Percent┬áDiameter┬áStenosis]
Mean ± Standard Deviation
  73.0  ± 12.6  
[1] More than one Cardiac History measure may be reported for each participant.
[2] More than one Cardiac Risk Factor may be reported for each participant.
[3] Analysis is based on the number of intent-to-treat lesions (n=67).



  Outcome Measures
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1.  Primary:   Device Procedural Success   [ Time Frame: Peri-procedural ]

2.  Secondary:   In-hospital Major Adverse Cardiac Events (MACE)   [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 24 hours) ]


  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: Andrey Nersesov, Clinical Trial Manager
Organization: Boston Scientific
phone: 1-508-683-4988
e-mail: Andrey.Nersesov@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01635881     History of Changes
Other Study ID Numbers: S2228
Study First Received: May 25, 2012
Results First Received: August 9, 2013
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration