SPIRIT PRIME Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00916370
First received: June 5, 2009
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Interventions: Device: Core size Xience Prime
Device: Xience Prime Long Lesion (LL)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled into this trial will be male and female subjects from the general interventional cardiology population. The study commenced on June 5, 2009 with the first subject enrolled on June 15, 2009. The last subject in the CSR was enrolled February 12, 2010, and the last subject enrolled in LLR was on April 6, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Core Size Registry Core size indicates the range of diameters of the stents used.
Long Lesion Registry Use of long lesion stents.

Participant Flow:   Overall Study
    Core Size Registry     Long Lesion Registry  
STARTED     401     104  
COMPLETED     396     102  
NOT COMPLETED     5     2  
Death                 3                 1  
Withdrawal by Subject                 2                 0  
Physician Decision                 0                 1  



  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.
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Reporting Groups
  Description
Core Size Registry Core size indicates the range of diameters of the stents used.
Long Lesion Registry Use of long lesion stents.
Total Total of all reporting groups

Baseline Measures
    Core Size Registry     Long Lesion Registry     Total  
Number of Participants  
[units: participants]
  401     104     505  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     234     56     290  
>=65 years     167     48     215  
Age  
[units: years]
Mean ± Standard Deviation
  62.70  ± 10.23     63.46  ± 9.44     62.86  ± 10.07  
Gender  
[units: participants]
     
Female     119     39     158  
Male     282     65     347  
Region of Enrollment  
[units: participants]
     
United States     376     96     472  
Australia     25     8     33  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Procedure Time   [ Time Frame: From insertion to withdrawal of guide catheter ]

3.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: In-hospital is less than or equal to 7 days post index procedure ]

4.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI)Per Protocol - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure. ]

5.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

6.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

7.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

8.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

9.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

10.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

11.  Secondary:   Cardiac Death/All MI   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

12.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: in-hospital ]

13.  Secondary:   All Death/All MI/All Coronary Revascularization   [ Time Frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure ]

14.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 30 days ]

15.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 180 days ]

16.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 1 year ]

17.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 30 days ]

18.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 180 days ]

19.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 1 year ]

20.  Secondary:   Device Success (Lesion Basis)   [ Time Frame: From the start of index procedure to end of index procedure ]

21.  Secondary:   Procedural Success (Subject Basis)   [ Time Frame: From the start of index procedure to end of index procedure ]

22.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 30 days ]

23.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 180 days ]

24.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 1 year ]

25.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 30 days ]

26.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 180 days ]

27.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 1 year ]

28.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 30 days ]

29.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 180 days ]

30.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 1 year ]

31.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 30 days ]

32.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 180 days ]

33.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 1 year ]

34.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 30 days ]

35.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 180 days ]

36.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 1 year ]

37.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 30 days ]

38.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 180 days ]

39.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 1 year ]

40.  Secondary:   Cardiac Death/ All MI   [ Time Frame: 30 days ]

41.  Secondary:   Cardiac Death/All MI   [ Time Frame: 180 days ]

42.  Secondary:   Cardiac Death/All MI   [ Time Frame: 1 year ]

43.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 30 days ]

44.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 180 days ]

45.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 1 year ]

46.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 30 days ]

47.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 180 days ]

48.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 1 year ]

49.  Secondary:   Stent Thrombosis (Per Protocol and Per ARC)   [ Time Frame: Acute (≤1 day) ]

50.  Secondary:   Stent Thrombosis (Per Protocol and Per ARC)   [ Time Frame: Subacute (>1 - 30 days) ]

51.  Secondary:   Stent Thrombosis (Per Protocol and Per ARC)   [ Time Frame: Acute/Subacute (0 - 30 days) ]

52.  Secondary:   Stent Thrombosis (Per Protocol and Per ARC)   [ Time Frame: Late (31 - 393 days) ]

53.  Secondary:   Stent Thrombosis (Per Protocol and Per ARC)   [ Time Frame: Overall (0-393 days) ]

54.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

55.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

56.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

57.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

58.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

59.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

60.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

61.  Secondary:   Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

62.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

63.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

64.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

65.  Secondary:   Non-target Vessel MI (Q-wave, Non Q-wave)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

66.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

67.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

68.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

69.  Secondary:   Clinically Indicated-Target Lesion Revascularization   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

70.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

71.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

72.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

73.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

74.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

75.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

76.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

77.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

78.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

79.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

80.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

81.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

82.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

83.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

84.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

85.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

86.  Secondary:   Cardiac Death/All MI   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

87.  Secondary:   Cardiac Death/All MI   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

88.  Secondary:   Cardiac Death/All MI   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

89.  Secondary:   Cardiac Death/All MI   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

90.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

91.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

92.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

93.  Secondary:   Cardiac Death/ All MI/CI-TLR   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

94.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

95.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

96.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

97.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting 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 The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Smith Jr, Ph.D., Sr Clinical Research Scientist
Organization: Abbott Vascular
phone: 408-845-8265
e-mail: robert.smithjr@av.abbott.com


No publications provided


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00916370     History of Changes
Other Study ID Numbers: 06-373
Study First Received: June 5, 2009
Results First Received: May 1, 2012
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration