TAXUS PERSEUS Small Vessel (PERSEUS SV)

A Prospective Evaluation in a Non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels

The purpose of the TAXUS PERSEUS Small Vessel 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 20 mm in length in native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation

Detailed Description

This is a prospective, multi-center, single-arm superiority trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of ≤20 mm in length in native coronary arteries with visual RVD of ≥ 2.25 mm to < 2.75 mm diameter.

Two hundred twenty-four (224) subjects will be treated with the TAXUS Element stent at a maximum of 35 clinical sites. Follow-up at 30 days, 9 months including angiography) and 1 year will be completed in all subjects enrolled in the study. Eligible subjects will have annual follow-up until 5 years post-index procedure.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235-3401
      • Medical Center East
  • California
    • Bakersfield, California, United States, 93301
      • Bakersfield Memorial Hospital
    • La Jolla, California, United States, 92037
      • Scripps Clinic
  • Delaware
    • Newark, Delaware, United States, 19718-0002
      • Christiana Hospital
  • Florida
    • Ocala, Florida, United States, 34471
      • MediQuest Research at Munroe Regional Medical Center
    • Sarasota, Florida, United States, 34239-2940
      • Sarasota Memorial Hospital
  • Illinois
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804-4140
      • Northern Indiana Research Alliance / Lutheran Hospital of Indiana
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Cardiac & Vascular Research Center of Northern Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-1195
      • Abbott Northwestern Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Hospital
  • New York
    • Liverpool, New York, United States, 13088
      • St. Joseph's Hospital Health Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203-5866
      • Carolinas Medical Center
    • Greensboro, North Carolina, United States, 27401
      • LeBauer Cardiovascular Research Foundation
    • Raleigh, North Carolina, United States, 27610
      • Wake Medical Center
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Columbus, Ohio, United States, 43214-3907
      • Riverside Methodist Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Foundation for Cardiovascular Research
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Health Heart Center
  • Texas
    • Houston, Texas, United States, 77030-2767
      • Methodist DeBakey Heart Center
    • San Antonio, Texas, United States, 78229
      • TexSAn Heart Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center
    • Spokane, Washington, United States, 99204
      • Sacred Heart Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • St. Mary's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) ≥ 2.25 mm to < 2.75 mm
  • Cumulative target lesion length ≤ 20 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAXUS Element Stent System	Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation; TAXUS Element stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)	Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.	9 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The number of participants who experience a TLF through 365 days post-procedure out of the patients 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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital; Principal Investigator: Louis A Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 20, 2007
• First Submitted That Met QC Criteria: June 20, 2007
• First Posted (Estimate): June 21, 2007

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: PES; paclitaxel-eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: S2043; S2043-PIVOT-2006