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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)

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: February 17, 2017
Last verified: February 2017
History of Changes
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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
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
  Hide 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
  Show All Outcome Measures

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

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

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   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:   Major Adverse Cardiac Events (MACE)   [ Time Frame: 30 days ]
  Show Outcome Measure 25

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

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

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

29.  Secondary:   Death   [ Time Frame: 30 days ]
  Show Outcome Measure 29

30.  Secondary:   Death   [ Time Frame: 6 months ]
  Show Outcome Measure 30

31.  Secondary:   Death   [ Time Frame: 1 year ]
  Show Outcome Measure 31

32.  Secondary:   Death   [ Time Frame: 2 years ]
  Show Outcome Measure 32

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
  Show Serious Adverse Events


  Other Adverse Events
  Show 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
  Hide 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
Study First Received: September 13, 2011
Results First Received: November 14, 2014
Last Updated: February 17, 2017