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EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions (EXPERT CTO)

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ClinicalTrials.gov Identifier: NCT01435031
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : November 25, 2014
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease (CAD)
Chronic Total Occlusion (CTO)
Intervention: Device: CTO Treatment Device

  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 250 subjects were enrolled in 20 sites from September 13, 2011 to February 7, 2013. Twenty-eight participants were excluded from ITT (N=222) in whom recanalization and pre-dilatation of the target lesion were not completed and/or study stent was not inserted into the coronary guiding catheter.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
ITT set included 222 subjects who met entry criteria, were enrolled in the trial and whose target lesion was successfully crossed and predilated. PP set included all ITT subjects (N = 183) in whom at least 1 study stent was implanted,met procedure success,had follow-up data and had no major protocol deviations due to inappropriate enrollment.

Reporting Groups
  Description
CTO Treatment

Subjects receiving at least 1 of the following for the treatment of CTO:

  • XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
  • HT PROGRESS and/or HT PILOT guide wires in recanalization
  • MINI-TREK Coronary Dilatation Catheter in predilatation

CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:

  • XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
  • HT PROGRESS and/or HT PILOT guide wires in recanalization
  • MINI-TREK Coronary Dilatation Catheter in predilatation

Participant Flow for 6 periods

 Period 1:   ITT at 1 Month
    CTO Treatment
STARTED   222 [1] 
COMPLETED   216 
NOT COMPLETED   6 
Withdrawal by Subject                1 
Death                1 
Lost to Follow-up                4 
[1] ITT population

Period 2:   ITT at 6 Months
    CTO Treatment
STARTED   216 
COMPLETED   211 
NOT COMPLETED   5 
Death                2 
Lost to Follow-up                3 

Period 3:   ITT at 1 Year
    CTO Treatment
STARTED   211 
COMPLETED   202 
NOT COMPLETED   9 
Death                1 
Withdrawal by Subject                2 
Lost to Follow-up                6 

Period 4:   ITT at 2 Years
    CTO Treatment
STARTED   202 
COMPLETED   189 
NOT COMPLETED   13 
Death                7 
Withdrawal by Subject                2 
Lost to Follow-up                4 

Period 5:   ITT at 3 Years
    CTO Treatment
STARTED   189 
COMPLETED   178 
NOT COMPLETED   11 
Death                5 
Withdrawal by Subject                2 
Lost to Follow-up                4 

Period 6:   ITT at 4 Years
    CTO Treatment
STARTED   178 
COMPLETED   171 
NOT COMPLETED   7 
Death                4 
Withdrawal by Subject                2 
Lost to Follow-up                1 



  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.
ITT subjects (N=222) include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.

Reporting Groups
  Description
CTO Treatment

Subjects receiving at least 1 of the following for the treatment of CTO:

  • XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
  • HT PROGRESS and/or HT PILOT guide wires in recanalization
  • MINI-TREK Coronary Dilatation Catheter in predilatation

CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:

  • XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
  • HT PROGRESS and/or HT PILOT guide wires in recanalization
  • MINI-TREK Coronary Dilatation Catheter in predilatation

Baseline Measures
   CTO Treatment 
Overall Participants Analyzed 
[Units: Participants]
 		 222 
Age 
[Units: Years]
Mean (Standard Deviation) 		 61.65  (10.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      42  18.9% 
Male      180  81.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
American Indian or Alaska Native      1   0.5% 
Asian      9   4.1% 
Native Hawaiian or Other Pacific Islander      1   0.5% 
Black or African American      16   7.2% 
White      178  80.2% 
More than one race      17   7.7% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 		 
United States   222 
Clinical Characteristics 
[Units: Participants]
 		 
Prior Myocardial Infarction (MI)   61 
Previous Percutaneous Intervention (PCI)   96 
Prior Coronary Artery Bypass Graft Surgery   22 
Transient Ischemic Attack (TIA)   3 
Stroke   2 
Congestive Heart Failure   27 
Diabetes Mellitus   89 
Hypertension   203 
Dyslipidemia   215 
Renal Insufficiency/failure   1 
Atrial fibrillation   14 
History of bleeding   18 
Cancer   4 
Mental Illness   5 
Tobacco use [1] 
[Units: Participants]
 		 
Never used tobacco   65 
Former user, quit more than 1 month ago   89 
Current or former, quit within the past month   54 
[1] Evaluated in 208 subjects.
Number of diseased vessels 
[Units: Participants]
 		 
Single   170 
Double   38 
Triple   14 


  Outcome Measures

1.  Primary:   Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)   [ Time Frame: 1 year ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 4

5.  Primary:   Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 5

6.  Secondary:   Minimum Lumen Diameter (MLD): Pre-procedure   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 6

7.  Secondary:   Minimum Lumen Diameter (MLD): Post-procedure   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With Change in TIMI Flow Grade: Post-procedure   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Participants With Device Success   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Participants With Procedure Success   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Participants With Procedural Success With Antegrade Crossing   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of Participants With Procedural Success With Knuckle Wire   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 14

15.  Secondary:   Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 15

16.  Secondary:   Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 16

17.  Secondary:   Percentage of Participants With Procedural Success With Reverse CART   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 17

18.  Secondary:   Percentage of Participants With Procedural Success With Kissing Wire Technique   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 18

19.  Secondary:   Percentage of Participants With Procedural Success With Sub Intimal Technique   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 19

20.  Secondary:   Percentage of Participants With Procedural Success With Multiple Crossing Techniques   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 20

21.  Secondary:   Resource Utilization: Procedural Time   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 21

22.  Secondary:   Resource Utilization: Fluoroscopic Time   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 22

23.  Secondary:   Resource Utilization: Contrast Volume   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 23

24.  Secondary:   Percentage of Participants With Clinically Significant Perforation   [ Time Frame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes ]
  Show Outcome Measure 24

25.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 30 days ]
  Show Outcome Measure 25

26.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 6 months ]
  Show Outcome Measure 26

27.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 1 year ]
  Show Outcome Measure 27

28.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 2 years ]
  Show Outcome Measure 28

29.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 3 years ]
  Show Outcome Measure 29

30.  Secondary:   Number of Participants With Major Adverse Cardiac Events (MACE)   [ Time Frame: 4 years ]
  Show Outcome Measure 30

31.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 30 days ]
  Show Outcome Measure 31

32.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 6 months ]
  Show Outcome Measure 32

33.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 1 year ]
  Show Outcome Measure 33

34.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 2 years ]
  Show Outcome Measure 34

35.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 3 years ]
  Show Outcome Measure 35

36.  Secondary:   Number of Participants Experiencing Death   [ Time Frame: 4 years ]
  Show Outcome Measure 36

37.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 30 days ]
  Show Outcome Measure 37

38.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 6 months ]
  Show Outcome Measure 38

39.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 1 year ]
  Show Outcome Measure 39

40.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 2 years ]
  Show Outcome Measure 40

41.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 3 years ]
  Show Outcome Measure 41

42.  Secondary:   Number of Participants Experiencing Cardiac Death   [ Time Frame: 4 years ]
  Show Outcome Measure 42

43.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 30 days ]
  Show Outcome Measure 43

44.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 6 months ]
  Show Outcome Measure 44

45.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 1 year ]
  Show Outcome Measure 45

46.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 2 years ]
  Show Outcome Measure 46

47.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 3 years ]
  Show Outcome Measure 47

48.  Secondary:   Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 4 years ]
  Show Outcome Measure 48

49.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 30 days ]
  Show Outcome Measure 49

50.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 6 months ]
  Show Outcome Measure 50

51.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 1 year ]
  Show Outcome Measure 51

52.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 2 years ]
  Show Outcome Measure 52

53.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 3 years ]
  Show Outcome Measure 53

54.  Secondary:   Number of Participants With Target Vessel-related MI   [ Time Frame: 4 years ]
  Show Outcome Measure 54

55.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 30 days ]
  Show Outcome Measure 55

56.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 6 months ]
  Show Outcome Measure 56

57.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 1 year ]
  Show Outcome Measure 57

58.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]
  Show Outcome Measure 58

59.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
  Show Outcome Measure 59

60.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 4 years ]
  Show Outcome Measure 60

61.  Secondary:   Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 30 days ]
  Show Outcome Measure 61

62.  Secondary:   Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 6 months ]
  Show Outcome Measure 62

63.  Secondary:   Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 1 year ]
  Show Outcome Measure 63

64.  Secondary:   Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 2 years ]
  Show Outcome Measure 64

65.  Secondary:   Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 3 years ]
  Show Outcome Measure 65

66.  Secondary:   Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 4 years ]
  Show Outcome Measure 66

67.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 30 days ]
  Show Outcome Measure 67

68.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 6 months ]
  Show Outcome Measure 68

69.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 1 year ]
  Show Outcome Measure 69

70.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 2 years ]
  Show Outcome Measure 70

71.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 3 years ]
  Show Outcome Measure 71

72.  Secondary:   Number of Participants With All Target Vessel Revascularization (TVR)   [ Time Frame: 4 years ]
  Show Outcome Measure 72

73.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 30 days ]
  Show Outcome Measure 73

74.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 6 months ]
  Show Outcome Measure 74

75.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 1 year ]
  Show Outcome Measure 75

76.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 2 years ]
  Show Outcome Measure 76

77.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 3 years ]
  Show Outcome Measure 77

78.  Secondary:   Number of Participants With Target Vessel Failure (TVF)   [ Time Frame: 4 years ]
  Show Outcome Measure 78

79.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 30 days ]
  Show Outcome Measure 79

80.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 6 months ]
  Show Outcome Measure 80

81.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 1 year ]
  Show Outcome Measure 81

82.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 2 years ]
  Show Outcome Measure 82

83.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 3 years ]
  Show Outcome Measure 83

84.  Secondary:   Number of Participants With Target Lesion Failure (TLF)   [ Time Frame: 4 years ]
  Show Outcome Measure 84

85.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: Acute (0-24 hours) ]
  Show Outcome Measure 85

86.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: Subacute (>24 hours to 30 days) ]
  Show Outcome Measure 86

87.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: Late (>30 days to 1 year) ]
  Show Outcome Measure 87

88.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: 1 year ]
  Show Outcome Measure 88

89.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: 2 years ]
  Show Outcome Measure 89

90.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: 3 years ]
  Show Outcome Measure 90

91.  Secondary:   Number of Participants With Stent Thrombosis   [ Time Frame: 4 years ]
  Show Outcome Measure 91

92.  Secondary:   Number of Participants With Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 1 year ]
  Show Outcome Measure 92

93.  Secondary:   Number of Participants With Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 2 years ]
  Show Outcome Measure 93

94.  Secondary:   Number of Participants With Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 3 years ]
  Show Outcome Measure 94

95.  Secondary:   Number of Participants With Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 4 years ]
  Show Outcome Measure 95


  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: Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
Organization: Abbott Vascular
phone: 408-845-1459
e-mail: jennifer.jones@av.abbott.com


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


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01435031     History of Changes
Other Study ID Numbers: 11-394
First Submitted: September 13, 2011
First Posted: September 15, 2011
Results First Submitted: November 14, 2014
Results First Posted: November 25, 2014
Last Update Posted: March 13, 2018