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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Withdrawn at Investigator's discretion                 3                 2  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  
Number of Participants  
[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  
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  
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  
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  
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  
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class [2]
[units: participants]
     
Type A     79     28     107  
Type B1     233     85     318  
Type B2     384     130     514  
Type C     246     77     323  
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [3]
[units: participants]
     
TIMI 0     2     2     4  
TIMI 1     4     0     4  
TIMI 2     34     4     38  
TIMI 3     902     314     1216  
[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.
[2]

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.

[3] 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


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

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