TAXUS PERSEUS Workhorse

Coronary Artery Disease Clinical Trial

— PERSEUS WH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484315
• Other study ID #: S2037
• Secondary ID: S2037-PIVOT-2006
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2007
• Last updated: April 24, 2014
• Start date: July 2007
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: MedsafeSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1264
• Est. completion date: October 2013
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
• Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure	The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.	9 months post-index procedure	Yes