TAXUS PERSEUS Small Vessel (PERSEUS SV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00489541
First received: June 20, 2007
Last updated: February 7, 2013
Last verified: February 2013
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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  
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  
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  
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  
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) [2]
[units: participants]
     
Type A     21     7     28  
Type B1     73     21     94  
Type B2     99     73     172  
Type C     31     24     55  
Lesion Characteristic: Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [3]
[units: participants]
     
TIMI 0     1     0     1  
TIMI 1     2     1     3  
TIMI 2     1     7     8  
TIMI 3     220     117     337  
[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
  Show All Outcome Measures

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


  More Information
  Hide More Information

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.


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
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.  


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: 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: February 7, 2013
Health Authority: United States: Food and Drug Administration