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XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

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ClinicalTrials.gov Identifier: NCT01086228
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Angina
Chronic Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Intervention: Device: XIENCE V / PROMUS stent

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 2010 patients were registered. Of which 1 patient was excluded from this analysis. Therefore, 2009 patients (1,159 patients treated with XIENCE V; 850 patients treated with PROMUS) were included in the analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study has excluded those patients who were treated with stents other than CoCr-EES (XIENCE V or PROMUS), or underwent concomitant treatment of a graft vessel. Patients were invited to enroll in the study after apparently successful per-cutaneous coronary intervention (PCI).

Reporting Groups
  Description
XIENCE V / PROMUS Stent

Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.

XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.


Participant Flow for 6 periods

Period 1:   8 Month Follow-up
    XIENCE V / PROMUS Stent
STARTED   2009 [1] 
COMPLETED   1938 
NOT COMPLETED   71 
[1] Analysis population

Period 2:   1-year Follow-up
    XIENCE V / PROMUS Stent
STARTED   1938 
COMPLETED   1894 
NOT COMPLETED   44 

Period 3:   2-year Follow-up
    XIENCE V / PROMUS Stent
STARTED   1894 
COMPLETED   1834 
NOT COMPLETED   60 

Period 4:   3-year Follow-up
    XIENCE V / PROMUS Stent
STARTED   1834 
COMPLETED   1767 
NOT COMPLETED   67 

Period 5:   4-year Follow-up
    XIENCE V / PROMUS Stent
STARTED   1767 
COMPLETED   1664 
NOT COMPLETED   103 

Period 6:   5-year Follow-up
    XIENCE V / PROMUS Stent
STARTED   1664 
COMPLETED   1012 
NOT COMPLETED   652 



  Baseline Characteristics

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.
Baseline characteristics were analyzed for 2,009 patients (XIENCE V:1,159 ; PROMUS : 850).

Reporting Groups
  Description
XIENCE V / PROMUS Stent

Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.

XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.


Baseline Measures
   XIENCE V / PROMUS Stent 
Overall Participants Analyzed 
[Units: Participants]
 2009 
Age 
[Units: Years]
Median (Standard Deviation)
 70.0  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      481  23.9% 
Male      1528  76.1% 
Region of Enrollment 
[Units: Participants]
 
Japan   2009 


  Outcome Measures

1.  Primary:   Number of Participants With Stent Thrombosis (ST) as Per ARC Definition   [ Time Frame: Post Procedure to 1 Year ]

2.  Primary:   Number of Participants With Stent Thrombosis (ST) as Per ARC Definition   [ Time Frame: From 1 Year to 2 Years ]

3.  Primary:   Number of Participants With Stent Thrombosis (ST) as Per ARC Definition   [ Time Frame: From 2 years to 3 years ]

4.  Secondary:   Number of Participants With Adverse Events Related to Anti-platelet Medication   [ Time Frame: From post-procedure to 1 year ]

5.  Secondary:   Number of Participants With Adverse Events Related to Anti-platelet Medication   [ Time Frame: From 1 year to 2 years ]

6.  Secondary:   Number of Participants With Adverse Events Related to Anti-platelet Medication   [ Time Frame: From 2 years to 3 years ]

7.  Secondary:   Number of Participants With Adverse Events Related to Anti-platelet Medication   [ Time Frame: From 3 years to 4 years ]

8.  Secondary:   Number of Participants With Adverse Events Related to Anti-platelet Medication   [ Time Frame: From 4 years to 5 years ]

9.  Secondary:   Percent Diameter Stenosis (%DS)   [ Time Frame: Baseline ]

10.  Secondary:   Percent Diameter Stenosis (%DS)   [ Time Frame: On day 0 after procedure ]

11.  Secondary:   Percent Diameter Stenosis (%DS)   [ Time Frame: At 8 months ]

12.  Secondary:   Acute Gain   [ Time Frame: On day 0 after procedure ]

13.  Secondary:   Late Loss   [ Time Frame: On day 0 after procedure ]

14.  Secondary:   Net Gain   [ Time Frame: On day 0 after procedure ]

15.  Secondary:   Acute Success   [ Time Frame: On day 0 (Immediately post-index procedure) ]

16.  Secondary:   Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)   [ Time Frame: Post Procedure to 1 Year ]

17.  Secondary:   Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)   [ Time Frame: From 1 to 2 years ]

18.  Secondary:   Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)   [ Time Frame: From 2 years to 3 years ]

19.  Secondary:   Number of Participants With Myocardial Infarctions (MI)   [ Time Frame: Post Procedure to 1 Year ]

20.  Secondary:   Number of Participants With Myocardial Infarctions (MI)   [ Time Frame: From 1 year to 2 years ]

21.  Secondary:   Number of Participants With Myocardial Infarctions (MI)   [ Time Frame: From 2 years to 3 years ]

22.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: Post Procedure to 1 Year ]

23.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: From 1 year to 2 years ]

24.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: From 2 years to 3 years ]

25.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: Post Procedure to 1 Year ]

26.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: From 1 Year to 2 Years ]

27.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: From 2 Years to 3 Years ]

28.  Secondary:   Number of Participants With Cardiac Death and All MI   [ Time Frame: Post Procedure to 1 Year ]

29.  Secondary:   Number of Participants With Cardiac Death and All MI   [ Time Frame: From 1 Year to 2 Years ]

30.  Secondary:   Number of Participants With Cardiac Death and All MI   [ Time Frame: From 2 Years to 3 Years ]

31.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: Post Procedure to 1 Year ]

32.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: From 1 Year to 2 Years ]

33.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: From 2 Years to 3 Years ]

34.  Secondary:   Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR   [ Time Frame: Post Procedure to 1 Year ]

35.  Secondary:   Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR   [ Time Frame: From 1 Year to 2 Years ]

36.  Secondary:   Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR   [ Time Frame: From 2 Years to 3 Years ]

37.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)   [ Time Frame: Post Procedure to 1 Year ]

38.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)   [ Time Frame: From 1 Year to 2 Years ]

39.  Secondary:   Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)   [ Time Frame: From 2 Years to 3 Years ]

40.  Secondary:   Number of Participants With All Deaths and All MI   [ Time Frame: Post Procedure to 1 Year ]

41.  Secondary:   Number of Participants With All Deaths and All MI   [ Time Frame: From 1 Year to 2 Years ]

42.  Secondary:   Number of Participants With All Deaths and All MI   [ Time Frame: From 2 Years to 3 Years ]

43.  Secondary:   Number of Participants With All Deaths, All MI and All Revascularization   [ Time Frame: Post Procedure to 1 Year ]

44.  Secondary:   Number of Participants With All Deaths, All MI and All Revascularization   [ Time Frame: From 1 Year to 2 Years ]

45.  Secondary:   Number of Participants With All Deaths, All MI and All Revascularization   [ Time Frame: From 2 Years to 3 Years ]

46.  Secondary:   Number of Participants With All Deaths, TVMI and TLR   [ Time Frame: Post Procedure to 1 Year ]

47.  Secondary:   Number of Participants With All Deaths, TVMI and TLR   [ Time Frame: From 1 Year to 2 Years ]

48.  Secondary:   Number of Participants With All Deaths, TVMI and TLR   [ Time Frame: From 2 Years to 3 Years ]

49.  Secondary:   Number of Participants With All Deaths, TVMI and CI-TLR   [ Time Frame: Post Procedure to 1 Year ]

50.  Secondary:   Number of Participants With All Deaths, TVMI and CI-TLR   [ Time Frame: From 1 Year to 2 Years ]

51.  Secondary:   Number of Participants With All Deaths, TVMI and CI-TLR   [ Time Frame: From 2 Years to 3 Years ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 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: David R Rutledge
Organization: Abbott Vascular
phone: (408) 845-3820
e-mail: david.rutledge@av.abbott.com


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

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01086228     History of Changes
Other Study ID Numbers: 09-384
First Submitted: March 11, 2010
First Posted: March 15, 2010
Results First Submitted: February 13, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018