Clinical trial NCT00489541: TAXUS PERSEUS Small Vessel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: paclitaxel-eluting stent
PES
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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) ≥ 2.25 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)

Primary outcomes:
measure: In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)
timeFrame: 9 months post-index procedure
Secondary outcomes:
measure: 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.
timeFrame: 12 months post-index procedure
Other outcomes:
Locations:
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: Scripps Clinic
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Ocala
country: United States
facility: Mediquest Research at Munroe Regional Medical Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
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: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
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: 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: Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
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: Seattle
country: United States
facility: Swedish 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
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: 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.