Clinical trial NCT00484315: TAXUS PERSEUS Workhorse
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: drug-eluting stent
paclitaxel-eluting stent
DES
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 1264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries ≥ 2.75 mm and ≤ 4.0 mm in diameter, compared to a control group of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System .

One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).

Eligible subjects will have annual follow-up until 5 years post-index procedure.

Eligibility criteria: Clinical Inclusion Criteria:

* 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 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)

Primary outcomes:
measure: 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.
timeFrame: 12 months post-index procedure
Secondary outcomes:
measure: In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
timeFrame: 9 months post-index procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: Medical Center East
state: Alabama
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: La Jolla
country: United States
facility: Alvarado Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Ocala
country: United States
facility: Mediquest Research at Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Foundation Hospitals
state: Hawaii
city: Evanston
country: United States
facility: Evanston Northwestern
state: Illinois
city: Rockford
country: United States
facility: St. Anthony's Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance / Lutheran Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Davenport
country: United States
facility: Trinity Terrace Park
state: Iowa
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: St. Joseph
country: United States
facility: Lakeland Hospitals at St. Joseph
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Mercy Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: St. Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albuquerque
country: United States
facility: Heart Hospital of New Mexico
state: New Mexico
city: Liverpool
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Greenville
country: United States
facility: University Medical Center-Greenville Memorial Hospital
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Methodist DeBakey Heart Center
state: Texas
city: San Antonio
country: United States
facility: TexSAn Heart Hospital
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: CaRE Foundation, Inc.
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Adelaide, SA, Australia
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincents Public,
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
Study officials:
affiliation: The Christ Hospital
name: Dean J Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac and Vascular Research Center of Northern Michigan
name: Louis A Cannon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Allocco 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.