PROMUS Element Plus US Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01589978
First received: May 1, 2012
Last updated: May 25, 2016
Last verified: May 2016
Results First Received: January 25, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: PROMUS Element Plus Coronary Stent System
Drug: Aspirin
Drug: P2Y12 antagonist

  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
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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
PROMUS Element Overall Population

Subjects who receive the PROMUS Element everolimus-eluting coronary stent.

Subgroups within the Overall Population Group:

PLATINUM-Like Patients N=776 (at time of Primary endpoint)

Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.

Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent.


Participant Flow:   Overall Study
    PROMUS Element Overall Population  
STARTED     2681  
COMPLETED     2681  
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
PROMUS Element Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Baseline Measures
    PROMUS Element  
Number of Participants  
[units: participants]
  2681  
Age [1]
[units: years]
Mean (Standard Deviation)
  63.7  (11.1)  
Gender [2]
[units: participants]
 
Female     807  
Male     1874  
Region of Enrollment  
[units: participants]
 
United States     2681  
Cardiac History [3]
[units: participants]
 
History of CAD     1625  
History of MI     1409  
History of CHF     275  
Stable Angina     620  
Unstable Angina     1347  
Silent Ischemia     149  
History of PCI     1159  
History of CABG     457  
Cardiac Risk Factors [3]
[units: participants]
 
Smoking, Ever     1600  
Current Diabetic Mellitus     989  
Hyperlipidemia Requiring Medication     2016  
History of Hypertension Requiring Medication     2077  
Family History of CAD     1625  
Lesion Characteristics: Target Lesion Vessel [4]
[units: lesions]
 
Left Anterior Descending Artery     1339  
Circumflex Artery     848  
Right Coronary Artery     1165  
Left Main     54  
Graft     199  
Lesion Characteristics: Lesion Length [5]
[units: mm]
Mean (Standard Deviation)
  17.0  (10.3)  
Lesion Characteristics: Reference Vessel Diameter [5]
[units: mm]
Mean (Standard Deviation)
  2.94  (0.51)  
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow [6]
[units: lesions]
 
0     359  
1     157  
2     487  
3     2539  
[1] Collected as part of a medical history during subject enrollment.
[2] Collected during subject enrollment.
[3]

Note: A single participant could potentially experience multiple categories listed below.

Collected as part of a medical history during subject enrollment.

[4]

Note: A single participant could potentially experience multiple categories listed below.

Site reported information collected post-enrollment from medical records.

[5] Site reported information collected post-enrollment from medical records.
[6]

Note: A single participant could potentially experience multiple categories listed below.

Site reported information collected post-enrollment from medical records. Stages range from TIMI 0 (no perfusion) to TIMI 3 (normal flow).

TIMI: Thrombolysis in Myocardial Infarction




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients   [ Time Frame: 12 months ]

2.  Secondary:   Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients   [ Time Frame: 12 months ]

3.  Secondary:   Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

4.  Secondary:   Rate of Longitudinal Stent Deformation   [ Time Frame: Index Procedure ]

5.  Secondary:   Major Adverse Cardiac Event Rate (MACE)   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

6.  Secondary:   Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

7.  Secondary:   Myocardial Infarction (MI) Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

8.  Secondary:   Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

9.  Secondary:   Cardiac Death Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

10.  Secondary:   Rate of Cardiac Death Events Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

11.  Secondary:   Target Vessel Revascularization (TVR) Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

12.  Secondary:   Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

13.  Secondary:   Cardiac Death or Myocardial Infarction (MI) Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

14.  Secondary:   Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

15.  Secondary:   Target Vessel Failure (TVF) Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

16.  Secondary:   Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

17.  Secondary:   All Death Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

18.  Secondary:   Non-cardiac Death Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

19.  Secondary:   All Death or Myocardial Infarction Rate   [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ]

20.  Secondary:   Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients   [ Time Frame: 12 Months ]

21.  Secondary:   ARC ST Rate in PLATINUM-like Population.   [ Time Frame: Annually through 5 years ]


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01589978     History of Changes
Other Study ID Numbers: S2066
Study First Received: May 1, 2012
Results First Received: January 25, 2016
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration