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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
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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 
Overall Participants Analyzed 
[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 
[1] More than one Cardiac History measure may be reported for each participant.
Cardiac Risk Factors [1] 
[Units: Participants]
 
Smoking, Ever   36 
Medically Treated Diabetes   21 
Hyperlipidemia Requiring Medication   51 
Hypertension Requiring Medication   56 
Family History of Coronary Artery Disease   37 
[1] More than one Cardiac Risk Factor may be reported for each participant.
Lesion Characteristic: Target Lesion Vessel [1] 
[Units: Lesions]
 
Left Anterior Descending Artery   26 
Circumflex Artery   14 
Right Coronary Artery   21 
Left Main Coronary Artery   1 
Graft   2 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristic: Lesion Location [1] 
[Units: Lesions]
 
Ostial   11 
Proximal   16 
Mid   32 
Distal   8 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristic: Lesion Length [1] 
[Units: Lesions]
 
Less than 18 mm   51 
From 18 and less than 26 mm   11 
Greater or equal to 26 mm   5 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristics [1] 
[Units: Lesions]
 
Thrombus   0 
Tortuosity, Any   9 
Calcification, Any   30 
Ulcerated   0 
Aneurysm   3 
Intimal Flap   0 
Total Occlusion   7 
Eccentric Lesion   40 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow [1] 
[Units: Lesions]
 
0 (no perfusion)   5 
1 (penetration with minimal perfusion)   2 
2 (partial perfusion)   1 
3 (complete perfusion)   59 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristics [1] 
[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) 
[1] Analysis is based on the number of intent-to-treat lesions (n=67).
Lesion Characteristic: Percent Diameter Stenosis [1] 
[Units: Percent Diameter Stenosis]
Mean (Standard Deviation)
 73.0  (12.6) 
[1] 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



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