TAXUS PERSEUS Small Vessel (PERSEUS SV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00489541
First received: June 20, 2007
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA) [ Time Frame: 9 months post-index procedure ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 12 months post-index procedure ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 224
Study Start Date: July 2007
Study Completion Date: October 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAXUS Element Stent System Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) ≥ 2.25 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489541

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

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00489541     History of Changes
Other Study ID Numbers: S2043, S2043-PIVOT-2006
Study First Received: June 20, 2007
Results First Received: April 28, 2011
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
paclitaxel-eluting stent
PES

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014