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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01435031
First received: September 13, 2011
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Coronary Artery Disease (CAD)
Chronic Total Occlusion (CTO)
Intervention: Device: CTO Treatment Device

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
250 subjects were enrolled in 20 sites from September 13, 2011 to February 7, 2013.

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 3 periods

Period 1:   ITT at 1 Month
    CTO Treatment  
STARTED     222 [1]
PP Population     183 [2]
COMPLETED     216  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Death                 1  
Lost to Follow-up                 4  
[1] ITT population
[2] PP population

Period 2:   ITT at 6 Months
    CTO Treatment  
STARTED     216  
COMPLETED     212  
NOT COMPLETED     4  
Death                 2  
Lost to Follow-up                 2  

Period 3:   ITT at 1 Year
    CTO Treatment  
STARTED     212  
COMPLETED     209  
NOT COMPLETED     3  
Death                 1  
Withdrawal by Subject                 2  



  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.
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  
Number of Participants  
[units: participants]
  222  
Age  
[units: years]
Mean ± Standard Deviation
  61.65  ± 10.43  
Gender  
[units: participants]
 
Female     42  
Male     180  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     9  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     16  
White     178  
More than one race     17  
Unknown or Not Reported     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  
Number of diseased vessels  
[units: participants]
 
Single     170  
Double     38  
Triple     14  
[1] Evaluated in 208 subjects.



  Outcome Measures
  Show All 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: From start of index procedure to end of index procedure ]

4.  Primary:   Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (MACE Includes Per Protocol Definition of MI)   [ Time Frame: From start of index procedure to end of index procedure ]

5.  Primary:   Angioplasty Predilatation-related: Successful Predilatation of the CTO   [ Time Frame: At time of procedure ]

6.  Secondary:   Minimum Lumen Diameter (MLD): Pre-procedure   [ Time Frame: From start of index procedure to end of index procedure ]

7.  Secondary:   Minimum Lumen Diameter (MLD): Post-procedure   [ Time Frame: From start of index procedure to end of index procedure ]

8.  Secondary:   Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure   [ Time Frame: From start of index procedure to end of index procedure ]

9.  Secondary:   Change in TIMI Flow Grade: Post-procedure   [ Time Frame: From start of index procedure to end of index procedure ]

10.  Secondary:   Device Success   [ Time Frame: From start of index procedure to end of index procedure ]

11.  Secondary:   Procedure Success   [ Time Frame: From start of index procedure to end of index procedure ]

12.  Secondary:   Procedural Success With Antegrade Crossing   [ Time Frame: From start of index procedure to end of index procedure ]

13.  Secondary:   Procedural Success With STAR Technique   [ Time Frame: From start of index procedure to end of index procedure ]

14.  Secondary:   Procedural Success With Knuckle Wire   [ Time Frame: From start of index procedure to end of index procedure ]

15.  Secondary:   Procedural Success With Primary Retrograde Wire Crossing   [ Time Frame: From start of index procedure to end of index procedure ]

16.  Secondary:   Procedural Success With Controlled Antegrade-Retrograde Technique (CART)   [ Time Frame: From start of index procedure to end of index procedure ]

17.  Secondary:   Procedural Success With Reverse CART   [ Time Frame: From start of index procedure to end of index procedure ]

18.  Secondary:   Procedural Success With Kissing Wire Technique   [ Time Frame: From start of index procedure to end of index procedure ]

19.  Secondary:   Procedural Success With Sub Intimal Technique   [ Time Frame: From start of index procedure to end of index procedure ]

20.  Secondary:   Procedural Success With Multiple Crossing Techniques   [ Time Frame: From start of index procedure to end of index procedure ]

21.  Secondary:   Resource Utilization: Procedural Time   [ Time Frame: From start of index procedure to end of index procedure ]

22.  Secondary:   Resource Utilization: Fluoroscopic Time   [ Time Frame: From start of index procedure to end of index procedure ]

23.  Secondary:   Resource Utilization: Contrast Volume   [ Time Frame: From start of index procedure to end of index procedure ]

24.  Secondary:   Clinically Significant Perforation   [ Time Frame: From start of index procedure to end of index procedure ]

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:   Death   [ Time Frame: 30 days ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

63.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

67.  Secondary:   Death   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

71.  Secondary:   Cardiac Death   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

75.  Secondary:   Myocardial Infarction Q Wave and Non-Q Wave (MI)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

79.  Secondary:   Target Vessel-related MI   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

83.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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

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

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

87.  Secondary:   Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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

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

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

91.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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

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

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

95.  Secondary:   Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

99.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

103.  Secondary:   Target Lesion Failure (TLF)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

107.  Secondary:   Stent Thrombosis   [ Time Frame: very late (>1 year) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

108.  Secondary:   Stent Thrombosis   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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

112.  Secondary:   Occurrence of Stent Fracture at Target Lesion   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

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

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

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


  Serious Adverse Events


  Other Adverse Events


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


No publications provided


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01435031     History of Changes
Other Study ID Numbers: 11-394
Study First Received: September 13, 2011
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration