TAXUS PERSEUS Workhorse
PERSEUS WH
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
2 other identifiers
interventional
1,264
4 countries
90
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Jul 2007
Longer than P75 for phase_3 coronary-artery-disease
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedResults Posted
Study results publicly available
June 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 8, 2014
April 1, 2014
2.2 years
June 6, 2007
April 28, 2011
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.
12 months post-index procedure
Secondary Outcomes (1)
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
9 months post-index procedure
Study Arms (2)
TAXUS Element
EXPERIMENTALTAXUS Express
ACTIVE COMPARATORInterventions
TAXUS Element stent placement
TAXUS Express Stent Implant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Medical Center East
Birmingham, Alabama, 35235-3401, United States
Bakersfield Memorial Hospital
Bakersfield, California, 93301, United States
Alvarado Hospital
La Jolla, California, 92037, United States
Scripps Clinic
La Jolla, California, 92037, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Mercy General Hospital
Sacramento, California, 95819, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120, United States
Christiana Hospital
Newark, Delaware, 19718-0002, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017, United States
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Florida Hospital
Orlando, Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239-2940, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Medical Center of Central Georgia
Macon, Georgia, 31208, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96817, United States
Evanston Northwestern
Evanston, Illinois, 60201, United States
St. Anthony's Medical Center
Rockford, Illinois, 61107, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
Northern Indiana Research Alliance / Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804-4140, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202, United States
St. Vincent's Hospital
Indianapolis, Indiana, 46290, United States
Trinity Terrace Park
Davenport, Iowa, 52803, United States
Iowa Heart Center
Des Moines, Iowa, 50134, United States
Maine Medical Center
Portland, Maine, 04102-3134, United States
Union Memorial Hospital
Baltimore, Maryland, 21218-2829, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912-6367, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Cape Cod Research Institute
Hyannis, Massachusetts, 02601, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, 49085-2112, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407-1195, United States
Mercy Hospital
Minneapolis, Minnesota, 55433, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
St. Anthony's Medical Center
St Louis, Missouri, 63128-2106, United States
Nebraska Heart Hospital
Lincoln, Nebraska, 68526, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Heart Hospital of New Mexico
Albuquerque, New Mexico, 87102, United States
St. Joseph's Hospital Health Center
Liverpool, New York, 13088, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203-5866, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-0001, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214-3907, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Main Line Health Heart Center
Bryn Mawr, Pennsylvania, 19010, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204-1018, United States
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660-3831, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-7235, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226, United States
Methodist DeBakey Heart Center
Houston, Texas, 77030-2767, United States
TexSAn Heart Hospital
San Antonio, Texas, 78229, United States
Trinity Mother Frances Health System
Tyler, Texas, 75701, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Lynchburg General Hospital
Lynchburg, Virginia, 24501, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507-1904, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
St. Mary's Medical Center
Huntington, West Virginia, 25701, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
CaRE Foundation, Inc.
Wausau, Wisconsin, 54401, United States
Royal Adelaide Hospital, Adelaide, SA, Australia
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
St. Vincents Public,
Fitzroy, Victoria, 3065, Australia
Auckland City Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 8001, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Wellington Hospital
Wellington, New Zealand
National Heart Centre
Singapore, 168752, Singapore
Related Publications (2)
Kereiakes DJ, Cannon LA, Feldman RL, Popma JJ, Magorien R, Whitbourn R, Dauber IM, Rabinowitz AC, Ball MW, Bertolet B, Kabour A, Foster MC, Wang JC, Underwood P, Dawkins KD. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):264-71. doi: 10.1016/j.jacc.2010.04.011. Epub 2010 May 20.
PMID: 20493653DERIVEDAllocco DJ, Cannon LA, Britt A, Heil JE, Nersesov A, Wehrenberg S, Dawkins KD, Kereiakes DJ. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials. 2010 Jan 7;11:1. doi: 10.1186/1745-6215-11-1.
PMID: 20059766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Andrey Nersesov, Clinical Project Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Dean J Kereiakes, MD
The Christ Hospital
- PRINCIPAL INVESTIGATOR
Louis A Cannon, MD
Cardiac and Vascular Research Center of Northern Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2007
First Posted
June 8, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2009
Study Completion
October 1, 2013
Last Updated
May 8, 2014
Results First Posted
June 28, 2011
Record last verified: 2014-04