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EXCEL Clinical Trial (EXCEL)

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ClinicalTrials.gov Identifier: NCT01205776
Recruitment Status : Active, not recruiting
First Posted : September 20, 2010
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Coronary Occlusion
Unprotected Left Main Coronary Artery Disease
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Interventions: Device: Percutaneous Coronary Intervention
Procedure: CABG

  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 1905 subjects were randomized (Percutaneous Coronary Intervention (PCI): 948 & Coronary Artery Bypass Graft (CABG) 957) between September 29, 2010 and March 6, 2014. Five hundred and forty-nine (549) subjects were from 56 U.S. sites and 1356 subjects were from 70 international sites,for a total of 126 enrolling sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The original EXCEL study consisted of a randomized clinical trial (RCT) (n=2600) & a Universal Registry (n=1000). In February 2014,a decision was made to cap enrollment in the RCT at approximately 1900.The change in scope of the study design was not due to any device or subject safety issues.

Reporting Groups
  Description
Percutaneous Coronary Intervention (PCI) Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Coronary Artery Bypass Graft (CABG) Those patients receiving Coronary Artery Bypass Graft (CABG)

Participant Flow for 3 periods

Period 1:   1 Month Follow-up
    Percutaneous Coronary Intervention (PCI)   Coronary Artery Bypass Graft (CABG)
STARTED   948   957 
COMPLETED   943   945 
NOT COMPLETED   5   12 
Lost to Follow-up                0                2 
Withdrawal by Subject                5                10 

Period 2:   2 Years Follow-up
    Percutaneous Coronary Intervention (PCI)   Coronary Artery Bypass Graft (CABG)
STARTED   943   945 
COMPLETED   927   913 
NOT COMPLETED   16   32 
Lost to Follow-up                12                13 
Withdrawal by Subject                4                19 

Period 3:   3 Years Follow-up
    Percutaneous Coronary Intervention (PCI)   Coronary Artery Bypass Graft (CABG)
STARTED   927   913 
COMPLETED   911   889 
NOT COMPLETED   16   24 
Lost to Follow-up                15                22 
Withdrawal by Subject                1                2 



  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.
No text entered.

Reporting Groups
  Description
Percutaneous Coronary Intervention (PCI) Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Coronary Artery Bypass Graft (CABG) Those patients receiving Coronary Artery Bypass Graft (CABG)
Total Total of all reporting groups

Baseline Measures
   Percutaneous Coronary Intervention (PCI)   Coronary Artery Bypass Graft (CABG)   Total 
Overall Participants Analyzed 
[Units: Participants]
 948   957   1905 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.0  (9.6)   65.9  (9.5)   66.0  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      722  76.2%      742  77.5%      1464  76.9% 
Male      226  23.8%      215  22.5%      441  23.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      21   2.2%      23   2.4%      44   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      36   3.8%      28   2.9%      64   3.4% 
White      844  89.0%      853  89.1%      1697  89.1% 
More than one race      16   1.7%      20   2.1%      36   1.9% 
Unknown or Not Reported      31   3.3%      33   3.4%      64   3.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Europe   534   541   1075 
United States   278   271   549 
Canada   103   100   203 
Southeast Asia   7   8   15 
Australia   6   9   15 
South America   20   28   48 


  Outcome Measures

1.  Primary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 3 years ]

2.  Secondary:   Numberof Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 30 days ]

3.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: 3 years ]

4.  Secondary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

5.  Secondary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 0 to 6 months ]

6.  Secondary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 0 to 1 year ]

7.  Secondary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 0 to 2 years ]

8.  Secondary:   Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke   [ Time Frame: 0 to 3 years ]

9.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

10.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: 0-30 days ]

11.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: 0 to 6 months ]

12.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: 0 to 1 year ]

13.  Secondary:   Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia   [ Time Frame: 0 to 2 years ]

14.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

15.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: 0-30 days ]

16.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: 0 to 1 year ]

17.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: 0 to 6 months ]

18.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: 0 to 2 years ]

19.  Secondary:   Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)   [ Time Frame: 0 to 3 years ]

20.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

21.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: 0-30 days ]

22.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: 0 to 6 months ]

23.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: 0 to 1 year ]

24.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: 0 to 2 years ]

25.  Secondary:   Number of Participants With Protocol Defined MI   [ Time Frame: 0 to 3 years ]

26.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

27.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: 0-30 days ]

28.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: 0 to 6 months ]

29.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: 0 to 1 year ]

30.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: 0 to 2 years ]

31.  Secondary:   Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)   [ Time Frame: 0 to 3 years ]

32.  Secondary:   Number of Participants With Disability Following Stroke Event   [ Time Frame: 90 days ± 2 weeks ]

33.  Secondary:   Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

34.  Secondary:   Number of Participants With Ischemia Driven Revascularizations   [ Time Frame: 0-30 days ]

35.  Secondary:   Number of Participants With Ischemia Driven Revascularizations   [ Time Frame: 0 to 6 months ]

36.  Secondary:   Number of Participants With Ischemia Driven Revascularizations   [ Time Frame: 0 to 1 year ]

37.  Secondary:   Number of Participants With Ischemia Driven Revascularizations   [ Time Frame: 0 to 2 years ]

38.  Secondary:   Number of Participants With Ischemia Driven Revascularizations   [ Time Frame: 0 to 3 years ]

39.  Secondary:   Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

40.  Secondary:   Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)   [ Time Frame: 0-30 days ]

41.  Secondary:   Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)   [ Time Frame: 0 to 6 months ]

42.  Secondary:   Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)   [ Time Frame: 0 to 1 year ]

43.  Secondary:   Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)   [ Time Frame: 0 to 2 years ]

44.  Secondary:   Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)   [ Time Frame: 0 to 3 years ]

45.  Secondary:   Percentage of Participants With Major Adverse Events (MAE)   [ Time Frame: in-hospital ]

46.  Secondary:   Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable   [ Time Frame: Acute (<= 24 hours) ]

47.  Secondary:   Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable   [ Time Frame: Subacute (1-30 days) ]

48.  Secondary:   Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable   [ Time Frame: Early (0-30 days) ]

49.  Secondary:   Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable   [ Time Frame: Late (>30 days - 1 year) ]

50.  Secondary:   Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable   [ Time Frame: Very late (>1 year) ]

51.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

52.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: 0-30 days ]

53.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: 0 to 6 months ]

54.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: 0 to 1 year ]

55.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: 0 to 2 years ]

56.  Secondary:   Number of Participants With Graft Stenosis or Occlusion   [ Time Frame: 0 to 3 years ]

57.  Secondary:   Number of Participants With Requirement for Blood Product Transfusion   [ Time Frame: 30 days ]

58.  Secondary:   Number of Participants With Requirement for Blood Product Transfusion   [ Time Frame: 3 years ]

59.  Secondary:   Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding   [ Time Frame: 30 days ]

60.  Secondary:   Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding   [ Time Frame: 3 years ]

61.  Secondary:   Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding   [ Time Frame: 30 days ]

62.  Secondary:   Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding   [ Time Frame: 3 years ]

63.  Secondary:   Number of Participants With Major Adverse Events (MAE)   [ Time Frame: 30 days ]

64.  Secondary:   Number of Participants With Complete Revascularization (Residual = 0)   [ Time Frame: At Baseline ]

65.  Secondary:   Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion   [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

66.  Secondary:   Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion   [ Time Frame: 1 year ]

67.  Secondary:   Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion   [ Time Frame: 2 years ]

68.  Secondary:   Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion   [ Time Frame: 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 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: Rhonda Hensley, Clinical Project Manager
Organization: Abbott Vascular
phone: +1 828-559-0080
e-mail: rhonda.hensley@abbott.com


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


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01205776     History of Changes
Other Study ID Numbers: 10-389
First Submitted: September 16, 2010
First Posted: September 20, 2010
Results First Submitted: March 1, 2018
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018