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TAXUS PERSEUS Small Vessel (PERSEUS SV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00489541
First received: June 20, 2007
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation

  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
Eligible subjects were enrolled at 28 United States centers between July 13, 2007 and August 27, 2008. All subjects were required to undergo angiographic assessment at 9 months. The historic control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522), including 108 with 9-month QCA follow-up.

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 Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
Historical Control Bare Metal Stent (BMS) The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).

Participant Flow for 2 periods

Period 1:   12-Month Clinical Follow-up
    TAXUS Element   Historical Control Bare Metal Stent (BMS)
STARTED   224   125 
COMPLETED   215   120 
NOT COMPLETED   9   5 
Withdrawal by Subject                2                3 
Lost to Follow-up                2                0 
Missed 12-Month Visit                2                0 
Death                3                2 

Period 2:   9-Month Angiographic Follow-up
    TAXUS Element   Historical Control Bare Metal Stent (BMS)
STARTED   224   125 
COMPLETED   197   108 
NOT COMPLETED   27   17 
No 9-Month Angiography Performed                23                12 
Not Evaluable for 9-Month Angiography                4                5 



  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 Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
Historical Control Bare Metal Stent (BMS) The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
Total Total of all reporting groups

Baseline Measures
   TAXUS Element   Historical Control Bare Metal Stent (BMS)   Total 
Overall Participants Analyzed 
[Units: Participants]
 224   125   349 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   100   63   163 
>=65 years   124   62   186 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (10.3)   64.2  (10.9)   64.5  (10.5) 
Gender 
[Units: Participants]
     
Female   81   49   130 
Male   143   76   219 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   11   3   14 
Caucasian   204   115   319 
Asian   0   0   0 
Black of African heritage   6   5   11 
Native Hawaiian or other Pacific Islander   0   0   0 
American Indian or Alaska native   1   0   1 
Other   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   224   125   349 
Cardiac History [1] 
[Units: Participants]
     
Previous Percutaneous Coronary Intervention (PCI)   92   42   134 
Previous Coronary Artery Bypass Graft (CABG)   41   24   65 
Previous Myocardial Infarction (MI)   57   36   93 
Congestive Heart Failure   18   3   21 
Stable Angina   136   70   206 
Unstable Angina   45   37   82 
Silent Ischemia   43   18   61 
[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)
 57.9  (9.4)   55.0  (9.2)   56.8  (9.4) 
Cardiac Risk Factors [1] 
[Units: Participants]
     
Smoking, Ever   137   69   206 
Medically Treated Diabetes   82   40   122 
Hyperlipidemia Requiring Medication   191   97   288 
Hypertension Requiring Medication   181   100   281 
Family History of Coronary Artery Disease   144   73   217 
[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   24   14   38 
Transient Ischemic Attack/Cerebrovascular Accident   21   5   26 
History of Renal Disease   9   0   9 
History of Gastrointestinal Bleeding   5   2   7 
[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   85   53   138 
Left Circumflex   93   45   138 
Right Coronary Artery   46   27   73 
Lesion Characteristic: Lesion Location 
[Units: Participants]
     
Ostial   14   5   19 
Proximal   91   42   133 
Mid   100   56   156 
Distal   19   22   41 
Lesion Characteristics 
[Units: Millimeters]
Mean (Standard Deviation)
     
Reference Vessel Diameter   2.1  (0.3)   2.2  (0.4)   2.1  (0.3) 
Minimum Lumen Diameter   0.6  (0.2)   0.6  (0.2)   0.6  (0.2) 
Lesion Length   11.7  (5.1)   12.9  (5.1)   12.1  (5.1) 
Sidebranch Stenosis   18.1  (24.6)   16.0  (21.2)   17.4  (23.4) 
Percent Diameter Stenosis 
[Units: Percent]
Mean (Standard Deviation)
 73.5  (10.2)   71.5  (10.4)   72.8  (10.3) 
Lesion Characteristics [1] 
[Units: Participants]
     
Eccentric Lesion   149   78   227 
Tortuosity, any   20   23   43 
Calcification, any   30   26   56 
Total Occlusion   3   1   4 
Bifurcation   53   27   80 
> 45 Degree Bend   14   15   29 
> 90 Degree Bend   0   0   0 
[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) [1] 
[Units: Participants]
     
Type A   21   7   28 
Type B1   73   21   94 
Type B2   99   73   172 
Type C   31   24   55 
[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   1   0   1 
TIMI 1   2   1   3 
TIMI 2   1   7   8 
TIMI 3   220   117   337 
[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:   In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)   [ Time Frame: 9 months post-index procedure ]

2.  Secondary:   Number of Participants With 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 ]


  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
There were no commercially available dedicated small vessel paclitaxel-eluting stents at the time of study enrollment, thus, the PERSEUS Small Vessel comparator group does not represent the most recently available paclitaxel-eluting stents.


  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: NCT00489541     History of Changes
Other Study ID Numbers: S2043
S2043-PIVOT-2006
Study First Received: June 20, 2007
Results First Received: April 28, 2011
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration