XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1) (XVU-Phase 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00676520
First received: October 16, 2007
Last updated: October 10, 2012
Last verified: October 2012
Results First Received: June 7, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Coronary Artery Disease
Intervention: Device: XIENCE V® Everolimus Eluting Coronary Stent

  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
Subjects are derived from the USA interventional cardiology population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A sub-set of subjects was randomized to the DAPT portion of this study.

Reporting Groups
  Description
Subjects Receiving the XIENCE V EECSS No text entered.

Participant Flow:   Overall Study
    Subjects Receiving the XIENCE V EECSS  
STARTED     8040  
COMPLETED     7309  
NOT COMPLETED     731  
Withdrawal by Subject                 163  
Lost to Follow-up                 162  
Death                 159  
Physician Decision                 20  
Ineligible for Randomization to DAPT                 209  
Other Reason                 18  



  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.
No text entered.

Reporting Groups
  Description
Subjects Receiving the XIENCE V EECSS No text entered.

Baseline Measures
    Subjects Receiving the XIENCE V EECSS  
Number of Participants  
[units: participants]
  8040  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4121  
>=65 years     3919  
Age  
[units: years]
Mean ± Standard Deviation
  64.58  ± 10.82  
Gender  
[units: participants]
 
Female     2441  
Male     5599  
Region of Enrollment  
[units: participants]
 
United States     8040  



  Outcome Measures
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1.  Primary:   Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).   [ Time Frame: up to 1 year ]

2.  Primary:   Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)   [ Time Frame: 1 year ]

3.  Secondary:   Clinical Device Success   [ Time Frame: acute: post index procedure until hospital discharge ]

4.  Secondary:   Procedural Success   [ Time Frame: acute: post index procedure until hospital discharge ]

5.  Secondary:   Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 30 days ]

6.  Secondary:   Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 180 days ]

7.  Secondary:   Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 30 days ]

8.  Secondary:   Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 180 days ]

9.  Secondary:   Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 1 year ]

10.  Secondary:   Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])   [ Time Frame: at 30 days ]

11.  Secondary:   Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])   [ Time Frame: at 180 days ]

12.  Secondary:   Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])   [ Time Frame: at 1 year ]

13.  Secondary:   Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)   [ Time Frame: at 30 days ]

14.  Secondary:   Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)   [ Time Frame: at 180 days ]

15.  Secondary:   Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)   [ Time Frame: at 1 year ]

16.  Secondary:   Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)   [ Time Frame: at 30 days ]

17.  Secondary:   Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)   [ Time Frame: at 180 days ]

18.  Secondary:   Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)   [ Time Frame: at 1 year ]

19.  Secondary:   Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 30 days ]

20.  Secondary:   Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 180 days ]

21.  Secondary:   Any MI (Q-wave and Non Q-wave)   [ Time Frame: at 1 year ]

22.  Secondary:   Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)   [ Time Frame: at 30 days ]

23.  Secondary:   Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)   [ Time Frame: at 180 days ]

24.  Secondary:   Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)   [ Time Frame: at 1 year ]

25.  Secondary:   Major Bleeding Complications   [ Time Frame: at 14 days ]

26.  Secondary:   Major Bleeding Complications   [ Time Frame: at 30 days ]

27.  Secondary:   Major Bleeding Complications   [ Time Frame: at 180 days ]

28.  Secondary:   Major Bleeding Complications   [ Time Frame: at 1 year ]

29.  Secondary:   Dual Antiplatelet Medication Usage   [ Time Frame: at 14 days ]

30.  Secondary:   Dual Antiplatelet Medication Usage   [ Time Frame: at 30 days ]

31.  Secondary:   Dual Antiplatelet Medication Usage   [ Time Frame: at 180 days ]

32.  Secondary:   Dual Antiplatelet Medication Usage   [ Time Frame: at 1 year ]

33.  Secondary:   Dual Antiplatelet Therapy Non-compliance Through 1 Year   [ Time Frame: 1 year ]

34.  Secondary:   Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)   [ Time Frame: at 30 days ]

35.  Secondary:   Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)   [ Time Frame: at 180 days ]

36.  Secondary:   Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)   [ Time Frame: at 1 year ]

37.  Secondary:   Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)   [ Time Frame: at baseline ]

38.  Secondary:   Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)   [ Time Frame: at 180 days ]

39.  Secondary:   Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)   [ Time Frame: at 1 year ]

40.  Secondary:   SAQ (Seattle Angina Questionaire)   [ Time Frame: at baseline ]

41.  Secondary:   SAQ (Seattle Angina Questionaire)   [ Time Frame: 180 days ]

42.  Secondary:   SAQ (Seattle Angina Questionaire)   [ Time Frame: 1 year ]


  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
No text entered.


  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 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: Ellen Travis
Organization: Abbott Vascular
phone: 408-845-3000
e-mail: Ellen.Travis@av.abbott.com


No publications provided by Abbott Vascular

Publications automatically indexed to this study:


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00676520     History of Changes
Other Study ID Numbers: 06-374
Study First Received: October 16, 2007
Results First Received: June 7, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration