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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
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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 
Overall Participants Analyzed 
[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 
[1] Note: A single participant could potentially experience multiple categories listed below.
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 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics: Target Lesion Vessel [1] 
[Units: Lesions]
 
Left Anterior Descending Artery   60 
Circumflex Artery   27 
Right Coronary Artery   32 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Location [1] 
[Units: Lesions]
 
Ostial   8 
Proximal   47 
Mid   49 
Distal   15 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Length [1] 
[Units: Lesions]
 
Less than or equal to 20 mm   91 
Greater than 20 mm   28 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics [1] 
[Units: Lesions]
 
Tortuosity, Any   10 
Calcification, Any   35 
Ulcerated   3 
Aneurysm   2 
Bifurcation   61 
Total Occlusion   2 
Eccentric Lesion   86 
[1] Note: A single participant could potentially experience multiple categories listed below.
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 
[1] Note: A single participant could potentially experience multiple categories listed below.
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 Diameter Stenosis]
Mean (Standard Deviation)
 69.12  (9.69) 


  Outcome Measures
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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


  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: Peter Maurer, Director Clinical Trials
Organization: Boston Scientific
phone: 508-683-6678
e-mail: Peter.Maurer@bsci.com



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