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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00484315




Registration number
NCT00484315
Ethics application status
Date submitted
6/06/2007
Date registered
8/06/2007
Date last updated
8/05/2014

Titles & IDs
Public title
TAXUS PERSEUS Workhorse
Scientific title
A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
Secondary ID [1] 0 0
S2037-PIVOT-2006
Secondary ID [2] 0 0
S2037
Universal Trial Number (UTN)
Trial acronym
PERSEUS WH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
Treatment: Devices - Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement

Experimental: TAXUS Element -

Active Comparator: TAXUS Express -


Treatment: Devices: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement

Treatment: Devices: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months post-index procedure
Secondary outcome [1] 0 0
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Timepoint [1] 0 0
9 months post-index procedure

Eligibility
Key inclusion criteria
Clinical

- Subject is = 18 years old

- Eligible for percutaneous coronary intervention (PCI)

- Documented stable angina pectoris (Canadian Cardiovascular Society [CCS]
Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C,
IIB-C, or IIIB-C), or documented silent ischemia

- Acceptable candidate for coronary artery bypass grafting (CABG)

- Left ventricular ejection fraction (LVEF) is = 30%

- Subject (or legal guardian) understands the study requirements and the treatment
procedures and provides written Informed Consent before any study-specific tests or
procedures are performed

- Subject willing to comply with all specified follow-up evaluations

Clinical
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine

- Known hypersensitivity to paclitaxel

- Known allergy to stainless steel

- Known allergy to platinum

- Previous treatment of the target vessel with any anti-restenotic drug-coated or
drug-eluting coronary stent

- Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months
of the index procedure

- Previous treatment of any non-target vessel with any anti-restenotic drug-coated or
drug-eluting coronary stent within 9 months of the index procedure

- Previous treatment with intravascular brachytherapy in the target vessel

- Planned PCI or CABG post-index procedure

- Planned or actual target vessel treatment with an unapproved device, directional or
rotational coronary atherectomy, laser, cutting balloon or transluminal extraction
catheter immediately prior to stent placement

- Myocardial infarction (MI) within 72 hours prior to index procedure

- Cerebrovascular accident (CVA) within the past 6 months

- Cardiogenic shock

- Acute or chronic renal dysfunction

- Prior anaphylactic reaction to contrast agents

- Leukopenia

- Thrombocytopenia

- Thrombocytosis

- Active peptic ulcer or active gastrointestinal (GI) bleeding

- Current treatment, or past-treatment within 12-months of the index procedure, with
paclitaxel or other chemotherapeutic agents

- Anticipated treatment with paclitaxel or oral rapamycin during any period in the
9-months after the index procedure

- Known intention to procreate within 9 months after the index procedure

- Positive pregnancy test within 7 days before the index procedure, or lactating

- Life expectancy of less than 24 months due to other medical conditions

- Co-morbid condition(s) that could limit subject's ability to comply with study
follow-up requirements or impact study scientific integrity

- Currently participating in another investigational drug or device study

Angiographic Inclusion Criteria:

- Target Lesion

- Target lesion located in native coronary artery

- Target lesion must be de novo

- Target lesion diameter stenosis = 50%

- Reference vessel diameter (RVD) = 2.75 mm to = 4.0 mm

- Cumulative target lesion length = 28 mm (area to be treated may be composed of
multiple lesions but must be completely coverable by one study stent)

- Target lesion is successfully pre-dilated

- One non-target lesion may be treated in a non-target vessel as follows:

- Non-target lesion in non-target vessel must be treated with commercially
available TAXUS stent if use of drug eluting stent required

- Treatment must be deemed a clinical angiographic success, without requiring use
of unplanned additional stents(s)

- Treatment must be completed prior to treatment of target vessel

Angiographic Exclusion Criteria

- Target lesion located in left main artery, whether protected or unprotected

- Target lesion is a chronic total occlusion (TIMI flow = 1)

- Target lesion is restenotic

- Target lesion is located in a saphenous vein graft or mammary artery graft

- Target lesion is accessed via saphenous vein graft or mammary artery graft

- Target lesion is < 5 mm from bare metal stent (BMS)

- Target lesion < 5 mm from ostium

- Target lesion < 5 mm from side branch vessel = 2.0 mm in diameter (Exceptions: subject
may be enrolled if side branch is 100% occluded or if side branch is protected with a
patent graft)

- Untreated lesions with = 50% diameter stenosis or thought to impair flow remaining in
target vessel at a location with = 2.0mm RVD

- Target lesion and/or target vessel proximal to target lesion moderately or severely
calcified

- Target lesion and/or target vessel proximal to target lesion severely tortuous

- Target lesion located within or distal to a > 60° bend in target vessel

- Target vessel with angiographic presence of probable or definite thrombus

- Unprotected left main coronary artery disease

- Protected left main coronary artery disease with target lesion in Left Anterior
Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if
only lesion is target lesion in Right Coronary Artery (RCA)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
1264
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital, Adelaide, SA, Australia - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
St. Vincents Public, - Fitzroy
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Colorado
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Iowa
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Hampshire
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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New Zealand
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Wellington
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Singapore
State/province [40] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of
the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS®
ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in
native coronary arteries of 2.75 mm to 4.0 mm diameter.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00484315
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dean J Kereiakes, MD
Address 0 0
The Christ Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00484315