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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01435031
Recruitment Status : Active, not recruiting
First Posted : September 15, 2011
Results First Posted : November 25, 2014
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):

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 (222) = those who met entry criteria, signed the consent form, were enrolled in the trial and whose target lesion was successfully crossed and predilated. PP set (183) = all ITT subjects 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 4 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   203 
NOT COMPLETED   8 
Death                1 
Withdrawal by Subject                2 
Lost to Follow-up                5 

Period 4:   ITT at 2 Years
    CTO Treatment
STARTED   203 
COMPLETED   194 
NOT COMPLETED   9 



  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:   Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)   [ Time Frame: 1 year ]

2.  Primary:   Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)   [ Time Frame: 1 year ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Primary:   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 ]

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 ]

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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

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

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

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

13.  Secondary:   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 ]

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

15.  Secondary:   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 ]

16.  Secondary:   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 ]

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

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

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 ]

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 ]

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 ]

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

25.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 30 days ]

26.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 6 months ]

27.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 1 year ]

28.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 2 years ]

29.  Secondary:   Death   [ Time Frame: 30 days ]

30.  Secondary:   Death   [ Time Frame: 6 months ]

31.  Secondary:   Death   [ Time Frame: 1 year ]

32.  Secondary:   Death   [ Time Frame: 2 years ]

33.  Secondary:   Cardiac Death   [ Time Frame: 30 days ]

34.  Secondary:   Cardiac Death   [ Time Frame: 6 months ]

35.  Secondary:   Cardiac Death   [ Time Frame: 1 year ]

36.  Secondary:   Cardiac Death   [ Time Frame: 2 years ]

37.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 30 days ]

38.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 6 months ]

39.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 1 year ]

40.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 2 years ]

41.  Secondary:   Target Vessel-related MI   [ Time Frame: 30 days ]

42.  Secondary:   Target Vessel-related MI   [ Time Frame: 6 months ]

43.  Secondary:   Target Vessel-related MI   [ Time Frame: 1 year ]

44.  Secondary:   Target Vessel-related MI   [ Time Frame: 2 years ]

45.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 30 days ]

46.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 6 months ]

47.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 1 year ]

48.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]

49.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 30 days ]

50.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 6 months ]

51.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 1 year ]

52.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 2 years ]

53.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 30 days ]

54.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 6 months ]

55.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 1 year ]

56.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 2 years ]

57.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 30 days ]

58.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 6 months ]

59.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 1 year ]

60.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 2 years ]

61.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 30 days ]

62.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 6 months ]

63.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 1 year ]

64.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 2 years ]

65.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 30 days ]

66.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 6 months ]

67.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 1 year ]

68.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 2 years ]

69.  Secondary:   Stent Thrombosis   [ Time Frame: Acute (0-24 hours) ]

70.  Secondary:   Stent Thrombosis   [ Time Frame: Subacute (>24 hours to 30 days) ]

71.  Secondary:   Stent Thrombosis   [ Time Frame: Late (>30 days to 1 year) ]

72.  Secondary:   Stent Thrombosis   [ Time Frame: 1 year ]

73.  Secondary:   Stent Thrombosis   [ Time Frame: 2 years ]

74.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 1 year ]

75.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 2 years ]

76.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

77.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

78.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

79.  Secondary:   Death   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

80.  Secondary:   Death   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

81.  Secondary:   Death   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

82.  Secondary:   Cardiac Death   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

83.  Secondary:   Cardiac Death   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

84.  Secondary:   Cardiac Death   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

85.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

86.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

87.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

88.  Secondary:   Target Vessel-related MI   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

89.  Secondary:   Target Vessel-related MI   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

90.  Secondary:   Target Vessel-related MI   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

91.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

92.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

93.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

94.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

95.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

96.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

97.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

98.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

99.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

100.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

101.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

102.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

103.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

104.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

105.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

106.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

107.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

108.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

109.  Secondary:   Stent Thrombosis   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

110.  Secondary:   Stent Thrombosis   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

111.  Secondary:   Stent Thrombosis   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

112.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

113.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

114.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: April 5, 2017