NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01703000
First received: October 5, 2012
Last updated: March 20, 2014
Last verified: March 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atherosclerosis
Coronary Artery Disease
Intervention: Device: Percutaneous coronary intervention (NG PROMUS)

  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 NG PROMUS study started on November 20, 2012 and completed on March 12, 2013. Subjects were recruited at 9 investigational centers in Australia, New Zealand and Singapore.

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
NG PROMUS Stent

Single-arm treatment group receiving interventional NG PROMUS study stent

Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.


Participant Flow:   Overall Study
    NG PROMUS Stent  
STARTED     100  
COMPLETED     99  
NOT COMPLETED     1  
Death                 1  



  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.

Single arm with investigational NG PROMUS Everolimus Eluting Coronary Stent System

N=100 patients, N=119 Lesions, N=127 Stents


Reporting Groups
  Description
NG PROMUS Stent

Single-arm treatment group receiving interventional NG PROMUS study stent

Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.


Baseline Measures
    NG PROMUS Stent  
Number of Participants  
[units: participants]
  100  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  61.72  ± 9.73  
Gender  
[units: participants]
 
Female     15  
Male     85  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic or Latino     2  
Caucasian     72  
Asian     13  
Black, of African Heritage     1  
Native Hawaiian or Other Pacific Islander     5  
Other     6  
Not disclosed     1  
Region of Enrollment  
[units: participants]
 
Singapore     10  
Australia     2  
New Zealand     88  
Cardiac History [1]
[units: participants]
 
Previous Percutaneous Coronary Intervention     23  
Previous Coronary Artery Bypass Graft     5  
Previous Myocardial Infarction     16  
Congestive Heart Failure     2  
Stable Angina     51  
Unstable Angina     25  
Silent Ischemia     7  
Cardiac Risk Factors [1]
[units: participants]
 
Smoking, Ever     56  
Medically Treated Diabetes     16  
Hyperlipidemia Requiring Medication     78  
Hypertension Requiring Medication     70  
Family History of Coronary Artery Disease     51  
Lesion Characteristics: Target Lesion Vessel [1]
[units: Lesions]
 
Left Anterior Descending Artery     60  
Circumflex Artery     27  
Right Coronary Artery     32  
Lesion Characteristic: Lesion Location [1]
[units: Lesions]
 
Ostial     8  
Proximal     47  
Mid     49  
Distal     15  
Lesion Characteristic: Lesion Length [1]
[units: Lesions]
 
Less than or equal to 20 mm     91  
Greater than 20 mm     28  
Lesion Characteristics [1]
[units: Lesions]
 
Tortuosity, Any     10  
Calcification, Any     35  
Ulcerated     3  
Aneurysm     2  
Bifurcation     61  
Total Occlusion     2  
Eccentric Lesion     86  
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow [1]
[units: Lesions]
 
0 (no perfusion)     0  
1 (penetration with minimal perfusion)     2  
2 (partial perfusion)     9  
3 (complete perfusion)     108  
Lesion Characteristics by Quantitative Cornary Angiography  
[units: Millimeters]
Mean ± Standard Deviation
 
Reference Vessel Diameter     2.78  ± 0.45  
Minimum Lumen Diameter     0.85  ± 0.29  
Lesion Length     16.05  ± 7.14  
Lesion Characteristic: Percent Diameter Stenosis by QCA  
[units: Percent┬áDiameter┬áStenosis]
Mean ± Standard Deviation
  69.12  ± 9.69  
[1] Note: A single participant could potentially experience multiple categories listed below.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Technical Success Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

2.  Secondary:   Target Lesion Revascularization (TLR) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

3.  Secondary:   Target Lesion Failure (TLF) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

4.  Secondary:   Target Vessel Revascularization (TVR) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

5.  Secondary:   Target Vessel Failure (TVF) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

6.  Secondary:   Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

7.  Secondary:   Cardiac Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

8.  Secondary:   Non-cardiac Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

9.  Secondary:   All Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

10.  Secondary:   Cardiac Death or MI Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

11.  Secondary:   All Death or MI Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

12.  Secondary:   All Death/MI/TVR Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

13.  Secondary:   Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days ]

14.  Secondary:   Clinical Procedural Success Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

15.  Secondary:   In-stent Percent Diameter Stenosis (%DS)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

16.  Secondary:   In-segment Percent Diameter Stenosis (%DS)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

17.  Secondary:   In-stent Minimum Lumen Diameter (MLD)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

18.  Secondary:   In-segment Minimum Lumen Diameter (MLD)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

19.  Secondary:   Acute Gain   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

20.  Secondary:   Vessel Area   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

21.  Secondary:   Stent Area   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

22.  Secondary:   Lumen Area   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

23.  Secondary:   Vessel Volume   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

24.  Secondary:   Stent Volume   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

25.  Secondary:   Lumen Volume   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

26.  Secondary:   Incomplete Apposition   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

27.  Secondary:   Percent Net Volume Obstruction   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

28.  Secondary:   Longitudinal Stent Deformation   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01703000     History of Changes
Other Study ID Numbers: NG PROMUS Clinical Trial S2294
Study First Received: October 5, 2012
Results First Received: December 16, 2013
Last Updated: March 20, 2014
Health Authority: Singapore: Health Sciences Authority
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe - Medicines and Medical Devices Safety Authority