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SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is ongoing, but not recruiting participants.
Study NCT00180479   Information provided by Abbott Vascular
First Received: September 13, 2005   Last Updated: September 18, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Conditions: Stents
Coronary Artery Disease
Total Coronary Occlusion
Coronary Artery Restenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Interventions: Device: XIENCE V® Everolimus Eluting Coronary Stent
Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

  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
1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.

Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Participant Flow:   Overall Study
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS
STARTED   669     333[1]
COMPLETED   653     320  
NOT COMPLETED   16     13  
      Death               4                 2  
      Lost to Follow-up               9                 7  
      Withdrawal by Subject               3                 3  
      Informed consent not signed               0                 1  
[1] 1 patient randomized never signed consent, therefore no data collected. Analysis group = 332.



  Baseline Characteristics
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Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Baseline Measures
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS Total
Number of Participants  
[units: participants]
 		669 333 1002
Age[1]
[units: participants]
 		     
<=18 years 0 0 0
Between 18 and 65 years 376 191 567
>=65 years 293 141 434
Age[2]
[units: years]
Mean ± Standard Deviation 		63.23 ± 10.53 62.80 ± 10.24 63.08 ± 10.43
Gender[3]
[units: participants]
 		     
Female 200 114 314
Male 469 218 687
Region of Enrollment[4]
[units: participants]
 		     
United States 669 333 1002
[1] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[2] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[3] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[4] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.



  Outcome Measures
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1.  Primary:   Primary Endpoint: In-segment Late Loss (LL)   [ 240 days ]
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Measure Type Primary
Measure Title Primary Endpoint: In-segment Late Loss (LL)
Measure Description In-segment minimal lumen diameter (MLD) post-procedure minus (–) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
Time Frame 240 days  
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.
Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.

Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Measured Values
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS
Number of Participants Analyzed
[units: participants] 		301 134
Primary Endpoint: In-segment Late Loss (LL)
[units: millimeters]
Mean ± Standard Deviation 		0.14 ± 0.41 0.28 ± 0.48


Statistical Analysis 1 for Primary Endpoint: In-segment Late Loss (LL)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] t-test, 1 sided
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Primary endpoint analyzed for intent-to-treat & per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.
[3] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)   [ 270 days ]
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3.  Secondary:   Target Vessel Failure (TVF)   [ 30 days ]
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4.  Secondary:   Target Vessel Failure (TVF)   [ 180 days ]
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5.  Secondary:   Target Vessel Failure (TVF)   [ 1 year ]
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6.  Secondary:   Target Vessel Failure (TVF)   [ 2 year ]
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7.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 30 days ]
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8.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 180 days ]
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9.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 270 days ]
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10.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 1 years ]
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11.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 2 years ]
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12.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 30 days ]
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13.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 180 days ]
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14.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 270 days ]
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15.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 1 year ]
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16.  Secondary:   Ischemia Drive Target Vessel Revascularization (ID-TVR)   [ 2 years ]
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17.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 30 days ]
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18.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 180 days ]
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19.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 270 days ]
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20.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 1 year ]
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21.  Secondary:   Ischemia Driven Major Adverse Cardiac Event(MACE)   [ 2 years ]
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22.  Secondary:   In-stent % Angiographic Binary Restenosis (% ABR) Rate   [ at 240 days ]
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23.  Secondary:   In-segment % Angiographic Binary Restenosis (% ABR) Rate   [ 240 days ]
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24.  Secondary:   Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection   [ at 240 days ]
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25.  Secondary:   Acute Success: Clinical Device   [ In-hospital ]
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26.  Secondary:   Acute Success: Clinical Procedure   [ In-hospital ]
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27.  Secondary:   Proximal Late Loss   [ at 240 days ]
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28.  Secondary:   Distal Late Loss   [ 240 days ]
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29.  Secondary:   In-stent Late Loss   [ at 240 days ]
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30.  Secondary:   % Volume Obstruction (% VO)   [ at 240 days ]
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31.  Secondary:   In-stent % Diameter Stenosis (% DS)   [ at 240 days ]
  Show Outcome Measure 31

32.  Secondary:   In-segment % Diameter Stenosis (% DS)   [ 240 days ]
  Show Outcome Measure 32


  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 NOT 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.


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: Matt Kiely, Manager Medical Information
Organization: Abbott Vascular
phone: 408-845-3477
e-mail: matthew.kiely@av.abbott.com


Publications of Results:
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13.
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. Epub 2009 Jan 26.
Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system:: clinical and angiographic results from the spirit III randomized trial. Catheter Cardiovasc Interv. 2009 Mar 24; [Epub ahead of print]


Responsible Party: Abbott Vascular ( Abbott Vascular )
Study ID Numbers: 03-360
Study First Received: September 13, 2005
Results First Received: October 15, 2008
Last Updated: September 18, 2009
ClinicalTrials.gov Identifier: NCT00180479     History of Changes
Health Authority: United States: Food and Drug Administration





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