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SPIRIT Small Vessel Registry (SPIRIT SV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00783796
First received: October 30, 2008
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
Results First Received: November 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Atherosclerosis
Myocardial Ischemia
Intervention: Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System

  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
150 subjects were recruited at 33 sites from the general interventional cardiology population. Dates of recruitment: 12/08/08 through 11/04/09.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened for study eligibility by a member of the study team. Subjects meeting eligibility criteria were asked to sign an informed consent form. Pre-procedure angiography was used for final assessment of eligibility.

Reporting Groups
  Description
2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® stent

Participant Flow:   Overall Study
    2.25mm XIENCE V®  
STARTED     150  
COMPLETED     144  
NOT COMPLETED     6  
Did not receive any stent                 4  
Received non-XIENCE V stent                 1  
Recieved commercial XIENCE V stent                 1  



  Baseline Characteristics
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Reporting Groups
  Description
2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® stent

Baseline Measures
    2.25mm XIENCE V®  
Number of Participants  
[units: participants]
 		  150  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     85  
>=65 years     65  
Age [1]
[units: years]
Mean ± Standard Deviation 		  62.97  ± 10.59  
Gender [2]
[units: percentage of participants]
 		 
Female     57  
Male     92  
Region of Enrollment  
[units: participants]
 		 
United States     150  
[1] This calculation is based on the FAS population (144 subjects), this removes 6 subjects who did recieve the 2.25 stent.
[2] One participant was deregistered from the study without recording their gender.



  Outcome Measures
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1.  Primary:   Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).   [ Time Frame: 1 year ]
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2.  Secondary:   Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)   [ Time Frame: From start of index procedure to end of index procedure ]
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3.  Secondary:   Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)   [ Time Frame: From the start of index procedure to end of index procedure ]
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4.  Secondary:   In-Stent Late Loss   [ Time Frame: 240 days ]
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5.  Secondary:   In-segment Late Loss (LL)   [ Time Frame: 240 Days ]
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6.  Secondary:   Proximal Late Loss   [ Time Frame: 240 days ]
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7.  Secondary:   Distal Late Loss   [ Time Frame: 240 days ]
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8.  Secondary:   In-stent % Diameter Stenosis   [ Time Frame: 240 days ]
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9.  Secondary:   In-segment % Diameter Stenosis   [ Time Frame: 240 days ]
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10.  Secondary:   Proximal % Diameter Stenosis   [ Time Frame: 240 days ]
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11.  Secondary:   Distal % Diameter Stenosis   [ Time Frame: 240 days ]
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12.  Secondary:   In-stent Angiographic Binary Restenosis (ABR) Rate   [ Time Frame: 240 days ]
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13.  Secondary:   In-segment Angiographic Binary Restenosis (ABR) Rate   [ Time Frame: 240 days ]
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14.  Secondary:   Proximal Angiographic Binary Restenosis (ABR) Rate   [ Time Frame: 240 days ]
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15.  Secondary:   Distal Angiographic Binary Restenosis (ABR) Rate   [ Time Frame: 240 days ]
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16.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 30 days ]
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17.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 240 days ]
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18.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 1 year ]
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19.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 2 years ]
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20.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 30 days ]
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21.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 240 days ]
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22.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 1 year ]
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23.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 2 years ]
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24.  Secondary:   Stent Thrombosis (ARC Defined)   [ Time Frame: 0 to 1 day (Acute) ]
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25.  Secondary:   Stent Thrombosis (ARC Defined)   [ Time Frame: greater than 1 day to 30 days (Subacute) ]
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26.  Secondary:   Stent Thrombosis (ARC Defined)   [ Time Frame: 31 days - 393 days (Late) ]
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27.  Secondary:   Stent Thrombosis (ARC Defined)   [ Time Frame: >1 year (Very late) ]
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28.  Secondary:   Stent Thrombosis (Protocol Defined)   [ Time Frame: 0 to 1 day (Acute) ]
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29.  Secondary:   Stent Thrombosis (Protocol Defined)   [ Time Frame: > 1 day to 30 days (Subacute) ]
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30.  Secondary:   Stent Thrombosis (Protocol Defined)   [ Time Frame: 31 days to 393 days (Late) ]
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31.  Secondary:   Stent Thrombosis (Protocol Defined)   [ Time Frame: 0-758 days ]
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32.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 30 days ]
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33.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 240 days ]
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34.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 1 year ]
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35.  Secondary:   All Death/ All MI/All Coronary Revascularization   [ Time Frame: 2 years ]
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36.  Secondary:   Cardiac Death/ All MI /CI-TLR   [ Time Frame: 30 days ]
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37.  Secondary:   Cardiac Death/ All MI /CI-TLR   [ Time Frame: 240 days ]
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38.  Secondary:   Cardiac Death/ All MI /CI-TLR   [ Time Frame: 1 year ]
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39.  Secondary:   Cardiac Death/ All MI /CI-TLR   [ Time Frame: 2 years ]
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40.  Secondary:   Cardiac Death/MI   [ Time Frame: 30 days ]
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41.  Secondary:   Cardiac Death/MI   [ Time Frame: 240 days ]
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42.  Secondary:   Cardiac Death/MI   [ Time Frame: 1 year ]
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43.  Secondary:   Cardiac Death/MI   [ Time Frame: 2 years ]
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44.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 30 days ]
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45.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 240 days ]
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46.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 1 year ]
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47.  Secondary:   All Coronary Revascularization (TVR and Non-TVR)   [ Time Frame: 2 years ]
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48.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 30 days ]
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49.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 240 days ]
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50.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 1 year ]
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51.  Secondary:   All TVR (CI and Non-CI)   [ Time Frame: 2 years ]
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52.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 30 days ]
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53.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 240 days ]
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54.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 1 year ]
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55.  Secondary:   All TLR (CI and Non-CI)   [ Time Frame: 2 years ]
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56.  Secondary:   Clinically Indicated Target Vessel Revascularization (TVR)   [ Time Frame: 30 days ]
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57.  Secondary:   Clinically Indicated Target Vessel Revascularization   [ Time Frame: 240 days ]
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58.  Secondary:   Clinically Indicated Target Vessel Revascularization   [ Time Frame: 1 year ]
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Measure Type Secondary
Measure Title Clinically Indicated Target Vessel Revascularization
Measure Description Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame 1 year  
Safety Issue Yes  

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.
Based on Full Analysis Set (FAS) population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent).

Reporting Groups
  Description
2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® stent

Measured Values
    2.25mm XIENCE V®  
Number of Participants Analyzed  
[units: participants]
 		  136  
Clinically Indicated Target Vessel Revascularization  
[units: Percentage of Participants]
Number ( 95% Confidence Interval ) 		  8.8  
  ( 4.64 to 14.91 )  

No statistical analysis provided for Clinically Indicated Target Vessel Revascularization



59.  Secondary:   Clinically Indicated Target Vessel Revascularization   [ Time Frame: 2 years ]
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60.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 30 days ]
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61.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 240 days ]
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62.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 1 year ]
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63.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 2 years ]
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64.  Secondary:   Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)   [ Time Frame: 30 days ]
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65.  Secondary:   Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)   [ Time Frame: 240 days ]
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66.  Secondary:   Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protcol)   [ Time Frame: 1 year ]
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67.  Secondary:   Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)   [ Time Frame: 2 years ]
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68.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 30 days ]
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69.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 240 days ]
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70.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 1 year ]
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71.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 2 years ]
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72.  Secondary:   Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)   [ Time Frame: 30 days ]
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73.  Secondary:   Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)   [ Time Frame: 240 days ]
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74.  Secondary:   Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)   [ Time Frame: 1 year ]
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75.  Secondary:   Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)   [ Time Frame: 2 years ]
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76.  Secondary:   All Death (Cardiac, Vascular, Non-cardiovascular)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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

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

79.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

80.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

81.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

82.  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

83.  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

84.  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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

103.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

104.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

105.  Secondary:   Clinically Indicated Target Lesion Revascularization (CI-TLR)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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

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

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

109.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

110.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

111.  Secondary:   Target Vessel MI - Q-wave and Non Q-wave (Per ARC)   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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.


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.  


Results Point of Contact:  
Name/Title: Ellen Travis
Organization: Abbott Vascular
phone: 408-845-3000
e-mail: Ellen.Travis@av.abbott.com


No publications provided


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00783796     History of Changes
Other Study ID Numbers: 08-383
Study First Received: October 30, 2008
Results First Received: November 29, 2011
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration