TAXUS PERSEUS Small Vessel

NCT ID: NCT00489541

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAXUS Element Stent System

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation

Intervention Type: DEVICE

TAXUS Element stent implantation

Interventions

Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation

TAXUS Element stent implantation

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean J Kereiakes, MD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital

Louis A Cannon, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiac and Vascular Research Center of Northern Michigan

Locations

Medical Center East

Birmingham, Alabama, United States

Bakersfield Memorial Hospital

Bakersfield, California, United States

Scripps Clinic

La Jolla, California, United States

Christiana Hospital

Newark, Delaware, United States

Mediquest Research at Munroe Regional Medical Center

Ocala, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

St. John's Hospital

Springfield, Illinois, United States

Northern Indiana Research Alliance / Lutheran Hospital of Indiana

Fort Wayne, Indiana, United States

Maine Medical Center

Portland, Maine, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Nebraska Heart Hospital

Lincoln, Nebraska, United States

St. Joseph's Hospital Health Center

Liverpool, New York, United States

Lenox Hill Hospital

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Wake Medical Center

Raleigh, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Main Line Health Heart Center

Bryn Mawr, Pennsylvania, United States

Methodist DeBakey Heart Center

Houston, Texas, United States

TexSAn Heart Hospital

San Antonio, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Sacred Heart Medical Center

Spokane, Washington, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20059766 (View on PubMed)

Other Identifiers

S2043-PIVOT-2006

Identifier Type: -

Identifier Source: secondary_id

S2043

Identifier Type: -

Identifier Source: org_study_id