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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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  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 ]

2.  Secondary:   Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)   [ 270 days ]

3.  Secondary:   Target Vessel Failure (TVF)   [ 30 days ]

4.  Secondary:   Target Vessel Failure (TVF)   [ 180 days ]

5.  Secondary:   Target Vessel Failure (TVF)   [ 1 year ]

6.  Secondary:   Target Vessel Failure (TVF)   [ 2 year ]

7.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 30 days ]

8.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 180 days ]

9.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 270 days ]

10.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 1 years ]

11.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 2 years ]

12.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 30 days ]

13.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 180 days ]

14.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 270 days ]

15.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 1 year ]

16.  Secondary:   Ischemia Drive Target Vessel Revascularization (ID-TVR)   [ 2 years ]

17.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 30 days ]

18.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 180 days ]

19.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 270 days ]

20.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 1 year ]

21.  Secondary:   Ischemia Driven Major Adverse Cardiac Event(MACE)   [ 2 years ]

22.  Secondary:   In-stent % Angiographic Binary Restenosis (% ABR) Rate   [ at 240 days ]

23.  Secondary:   In-segment % Angiographic Binary Restenosis (% ABR) Rate   [ 240 days ]

24.  Secondary:   Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection   [ at 240 days ]

25.  Secondary:   Acute Success: Clinical Device   [ In-hospital ]

26.  Secondary:   Acute Success: Clinical Procedure   [ In-hospital ]

27.  Secondary:   Proximal Late Loss   [ at 240 days ]

28.  Secondary:   Distal Late Loss   [ 240 days ]

29.  Secondary:   In-stent Late Loss   [ at 240 days ]

30.  Secondary:   % Volume Obstruction (% VO)   [ at 240 days ]

31.  Secondary:   In-stent % Diameter Stenosis (% DS)   [ at 240 days ]

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


  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:

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