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TAXUS PERSEUS Workhorse (PERSEUS WH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00484315
First received: June 6, 2007
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement

  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
Enrollment of 1264 subjects was planned; 1262 (942 TAXUS Element and 320 TAXUS Express) were enrolled and randomized at 90 centers by October 1, 2008. A total of 330 subjects were randomly assigned to protocol-mandated 9-month angiographic follow-up (angiographic subset).

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
TAXUS Element Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
TAXUS Express Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)

Participant Flow for 2 periods

Period 1:   12-Month Clinical Follow-up
    TAXUS Element   TAXUS Express
STARTED   942   320 
COMPLETED   914   311 
NOT COMPLETED   28   9 
Death                6                2 
Withdrawal by Subject                4                0 
Lost to Follow-up                2                1 
Missed 12-Month Visit                13                4 
Withdrawn at Investigator's discretion                3                2 

Period 2:   9-Month Angiographic Follow-up
    TAXUS Element   TAXUS Express
STARTED   256   74 
COMPLETED   228   61 
NOT COMPLETED   28   13 
No 9-Month Angiography Performed                25                11 
Not Evaluable for Angiography Analysis                3                2 



  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.
No text entered.

Reporting Groups
  Description
TAXUS Element Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
TAXUS Express Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
Total Total of all reporting groups

Baseline Measures
   TAXUS Element   TAXUS Express   Total 
Overall Participants Analyzed 
[Units: Participants]
 942   320   1262 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   540   163   703 
>=65 years   402   157   559 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (9.6)   63.5  (9.5)   62.5  (9.6) 
Gender 
[Units: Participants]
     
Female   275   100   375 
Male   667   220   887 
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
Hispanic or Latino   10   6   16 
Caucasian   872   296   1168 
Asian   15   6   21 
Black of African heritage   37   13   50 
Native Hawaiian or other Pacific Islander   4   1   5 
American Indian or Alaska native   3   0   3 
Other   4   0   4 
[1] The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Region of Enrollment 
[Units: Participants]
     
United States   859   290   1149 
Singapore   6   2   8 
Australia   60   22   82 
New Zealand   17   6   23 
Cardiac History [1] 
[Units: Participants]
     
Previous Percutaneous Coronary Intervention (PCI)   216   80   296 
Previous Coronary Artery Bypass Graft (CABG)   42   20   62 
Previous Myocardial Infarction (MI)   195   60   255 
Congestive Heart Failure   56   24   80 
Stable Angina   629   213   842 
Unstable Angina   195   68   263 
Silent Ischemia   117   39   156 
[1] The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Cardiac History: Ejection Fraction 
[Units: Ejection fraction percent]
Mean (Standard Deviation)
 58.0  (9.3)   57.8  (9.8)   57.9  (9.4) 
Cardiac Risk Factors [1] 
[Units: Participants]
     
Smoking, Ever   611   216   827 
Medically Treated Diabetes   232   80   312 
Hyperlipidemia Requiring Medication   717   243   960 
Hypertension Requiring Medication   709   256   965 
Family History of Coronary Artery Disease   589   196   785 
[1] The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Comorbidities [1] 
[Units: Participants]
     
History of Peripheral Vascular Disease   99   36   135 
History of Transient Ischemic Attack   30   14   44 
History of Cerebrovascular Accident   30   12   42 
History of Renal Disease   45   11   56 
History of Gastrointestinal Bleeding   9   7   16 
[1] The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristic: Target Lesion Vessel 
[Units: Participants]
     
Left Anterior Descending Artery   406   140   546 
Left Circumflex Artery   217   69   286 
Right Coronary Artery   319   111   430 
Lesion Characteristic: Lesion Location 
[Units: Participants]
     
Ostial   25   8   33 
Proximal   368   128   496 
Mid   485   154   639 
Distal   64   30   94 
Lesion Characteristics 
[Units: Millimeter]
Mean (Standard Deviation)
     
Reference Vessel Diameter   2.8  (0.5)   2.8  (0.5)   2.8  (0.5) 
Minimum Lumen Diameter   0.8  (0.3)   0.8  (0.4)   0.8  (0.3) 
Lesion Length   14.2  (6.1)   14.1  (5.8)   14.2  (6.0) 
Sidebranch Stenosis   24.4  (28.1)   25.7  (28.8)   24.7  (28.3) 
Lesion Characteristic: Percent Diameter Stenosis 
[Units: Percent]
Mean (Standard Deviation)
 72.1  (10.9)   71.7  (10.9)   72.0  (10.9) 
Lesion Characteristics [1] 
[Units: Participants]
     
Eccentric Lesion   487   161   648 
> 45 Degree Bend   61   22   83 
> 90 Degree Bend   2   1   3 
Tortuosity, any   59   14   73 
Calcification, any   228   86   314 
Total Occlusion   6   2   8 
Bifurcation   343   129   472 
[1] The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class [1] 
[Units: Participants]
     
Type A   79   28   107 
Type B1   233   85   318 
Type B2   384   130   514 
Type C   246   77   323 
[1]

Type A lesions: minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, and an absense of thrombus.

Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus.

Type C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.

Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [1] 
[Units: Participants]
     
TIMI 0   2   2   4 
TIMI 1   4   0   4 
TIMI 2   34   4   38 
TIMI 3   902   314   1216 
[1] TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion


  Outcome Measures
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1.  Primary:   Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.   [ Time Frame: 12 months post-index procedure ]

2.  Secondary:   In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure   [ Time Frame: 9 months post-index procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The comparator control for PERSEUS Workhorse study was chosen based on commercially available stent (TAXUS Express) at the time of study enrollment. Thus, the comparator group does not represent the most recently available paclitaxel-eluting stent.


  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: Andrey Nersesov, Clinical Project Manager
Organization: Boston Scientific
phone: 508-683-4988
e-mail: andrey.nersesov@bsci.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00484315     History of Changes
Other Study ID Numbers: S2037
S2037-PIVOT-2006
Study First Received: June 6, 2007
Results First Received: April 28, 2011
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Singapore: Health Sciences Authority