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SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study has been completed.
Study NCT00180479   Information provided by Abbott Vascular

First Received on September 13, 2005.   Last Updated on November 16, 2011   History of Changes
Results First Received: October 15, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
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 [1]
[units: years]
Mean ± Standard Deviation 		  63.23  ± 10.53     62.80  ± 10.24     63.08  ± 10.43  
Gender [1]
[units: participants]
 		     
Female     200     114     314  
Male     469     218     687  
Region of Enrollment [1]
[units: participants]
 		     
United States     669     333     1002  
[1] 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)   [ Time Frame: 240 days ]
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2.  Secondary:   Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)   [ Time Frame: 270 days ]
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3.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 30 days ]
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4.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 180 days ]
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5.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 1 year ]
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6.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 2 year ]
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7.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 3 year ]
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8.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 4 year ]
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9.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 30 days ]
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10.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 180 days ]
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11.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 270 days ]
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12.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 1 years ]
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13.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 2 years ]
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14.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 3 year ]
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15.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 4 year ]
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16.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 30 days ]
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17.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 180 days ]
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18.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 270 days ]
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19.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 1 year ]
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20.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 2 years ]
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21.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 3 years ]
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22.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 4 years ]
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23.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 30 days ]
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24.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 180 days ]
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25.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 270 days ]
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26.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 1 year ]
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27.  Secondary:   Ischemia Driven Major Adverse Cardiac Event(MACE)   [ Time Frame: 2 years ]
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28.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 3 year ]
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29.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 4 year ]
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30.  Secondary:   In-stent % Angiographic Binary Restenosis (% ABR) Rate   [ Time Frame: at 240 days ]
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31.  Secondary:   In-segment % Angiographic Binary Restenosis (% ABR) Rate   [ Time Frame: 240 days ]
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32.  Secondary:   Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection   [ Time Frame: at 240 days ]
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33.  Secondary:   Acute Success: Clinical Device   [ Time Frame: In-hospital ]
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34.  Secondary:   Acute Success: Clinical Procedure   [ Time Frame: In-hospital ]
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35.  Secondary:   Proximal Late Loss   [ Time Frame: at 240 days ]
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36.  Secondary:   Distal Late Loss   [ Time Frame: 240 days ]
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37.  Secondary:   In-stent Late Loss   [ Time Frame: at 240 days ]
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38.  Secondary:   % Volume Obstruction (% VO)   [ Time Frame: at 240 days ]
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39.  Secondary:   In-stent % Diameter Stenosis (% DS)   [ Time Frame: at 240 days ]
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40.  Secondary:   In-segment % Diameter Stenosis (% DS)   [ Time Frame: 240 days ]
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41.  Secondary:   Target Vessel Failure (TVF)   [ Time Frame: 5 years ]
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42.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ Time Frame: 5 years ]
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43.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ Time Frame: 5 years ]
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44.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ Time Frame: 5 years ]
  Show Outcome Measure 44


  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: Ellen Travis, Clinical Science
Organization: Abbott Vascular
phone: 408-845-1512
e-mail: Ellen.Travis@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]

Publications automatically indexed to this study:
Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15.
Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39.
Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8.


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180479     History of Changes
Other Study ID Numbers: 03-360
Study First Received: September 13, 2005
Results First Received: October 15, 2008
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration





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