Phase
Condition
Myocardial Ischemia
Coronary Artery Disease
Heart Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Inclusion Criteria:
Patient is ≥18 years old.
Eligible for percutaneous coronary intervention (PCI)
Documented stable angina pectoris or unstable angina pectoris with documented ischemiaor documented silent ischemia
Left ventricular ejection fraction (LVEF) of >/=25%
Acceptable candidate for coronary artery bypass grafting (CABG)
Patient or legal guardian understands the study requirements and the treatmentprocedures and provides written Informed Consent before any study-specific tests orprocedures are performed
Willing to comply with all specified follow-up evaluations Angiographic Inclusion Criteria:
Only one lesion (target lesion) may be treated with the study stent. However, oneadditional lesion in a non-target vessel may be treated during the index procedurewith a commercially available bare metal stent, heparin-coated stent or TAXUS Expressstent.
Target lesion enrolled for treatment may be composed of multiple lesions (not morethan 10mm between diseased segments)but must be completely covered by one study stent.
Target lesion located within a single native coronary artery
Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
Target lesion diameter stenosis ≥50% (visual estimate)
Target lesion is de novo (i.e., a coronary lesion not previously treated)
Exclusion
General Exclusion Criteria:
Known hypersensitivity to paclitaxel
Any previous, concurrent or planned treatment with a non-study anti-restenoticdrug-coated or drug-eluting coronary stent.
Previous or planned use of both the study stent and a non-study stent (i.e.,commercial stent) in the treatment of the target vessel
Previous or planned treatment with intravascular brachytherapy in the target vessel
Planned CABG ≤9-months post-index procedure
MI within 72 hours prior to the index procedure and or creatine kinase(CK) >2x thelocal laboratory's ULN unless CK-MB is <2x ULN.
Cerebrovascular Accident (CVA) within the past 6 months
Cardiogenic Shock
Acute or chronic renal dysfunction
Contraindication to ASA, or to both clopidogrel and ticlopidine
Leukopenia
Thrombocytopenia or thrombocytosis
Active peptic ulcer or active gastrointestinal (GI) bleeding
Known allergy to stainless steel
Any prior true anaphylactic reaction to contrast agents
Patient is currently, or has been treated with paclitaxel or other chemotherapeuticagents within 12-months of the index procedure
Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
Male or female with known intention to procreate within 3 months after the indexprocedure
Female of childbearing potential with a positive pregnancy test within 7 days beforethe index procedure, or lactating, or intends to become pregnant during the study.
Life expectancy of less than 24-months due to other medical condition
Co-morbid condition(s) that could limit the patient's ability to participate in thestudy, compliance with follow-up requirements or impact the scientific integrity ofthe study
Currently participating in another investigational drug or device study that has notcompleted the primary endpoint or that clinically interferes with the endpoints ofthis study. Angiographic Exclusion Criteria:
Left main coronary artery disease (stenosis >50%) whether protected or unprotected
Target lesion is ostial in location (within 3.0 mm of vessel origin)
Target lesion and/or target vessel proximal to the target lesion is moderately orseverely calcified by visual estimate.
Target lesion and/or target vessel proximal to the target lesion is tortuous.
Target lesion is located within or distal to a >60 degree bend in the vessel
Target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.
Target lesion is totally occluded (TIMI flow </= 1), either at baseline or predilation
Angiographic presence of probable or definite thrombus
Pre-treatment of the target vessel is not allowed with any device
Study Design
Connect with a study center
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Cardiovascular Research Center Monash Medical Centre
Clayton, Victoria 3168
AustraliaSite Not Available
Epworth Hospital
Richmond, Victoria 3121
AustraliaSite Not Available
Foothills Medical Centre
Calgary, Alberta T2N 2T9
CanadaSite Not Available
Vancouver General
Vancouver, British Columbia V5Z 1L8
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
CHUM Notre-Dame Hospital
Montreal, Quebec H2L 4M1
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Queen Elizabeth Hospital
Kowloon,
ChinaSite Not Available
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom 1003
New ZealandSite Not Available
Auckland City Hospital
Auckland, 1030
New ZealandSite Not Available
Christchurch Hospital
Christchurch,
New ZealandSite Not Available
Dunedin Hospital
Dunedin,
New ZealandSite Not Available
National Heart Centre
Singapore, 168752
SingaporeSite Not Available
National University Hospital
Singapore, 119074
SingaporeSite Not Available
Shin Kong Memorial Hospital
Shih Lin Taipei 111,
TaiwanSite Not Available
Cathay General Hospital
Taipei,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 100,
TaiwanSite Not Available
Chang-Gung Memorial Hospital, Kaohsiung
Taiwan, 83305
TaiwanSite Not Available
Chang-Gung Memorial Hospital, Linkou
Tao-Yuan,
TaiwanSite Not Available
Baptist Medical Center Princeton Cardiology PC
Birmingham, Alabama 35211
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
Brotman Medical Center
Beverly Hills, California 90210
United StatesSite Not Available
Mercy General Hospital
Sacramento, California 95819
United StatesSite Not Available
Salinas Valley Memorial Healthcare System
Salinas, California 93901
United StatesSite Not Available
University of California San Diego Medical Center
San Diego, California 92103-8784
United StatesSite Not Available
St. Joseph's Medical Center
Stockton, California 95204
United StatesSite Not Available
The Medical Center of Aurora
Aurora, Colorado 80012
United StatesSite Not Available
Christiana Hospital
Newark, Delaware 19718-0002
United StatesSite Not Available
George Washington University Medical Center
Washington, District of Columbia 20037
United StatesSite Not Available
Florida Hospital
Orlando, Florida 32803
United StatesSite Not Available
Rockford Cardiology Associates
Rockford, Illinois 61108
United StatesSite Not Available
Praire Cardiovascular Consultants, Ltd.
Springfield, Illinois 62701
United StatesSite Not Available
The Heart Center
Indianapolis, Indiana 46290
United StatesSite Not Available
Willis Knighton Medical Center
Shreveport, Louisiana 71103
United StatesSite Not Available
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Washington Adventist Hospital
Takoma Park, Maryland 20912
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Genesys Regional Medical Center
Grand Blanc, Michigan 48439
United StatesSite Not Available
Northern Michigan Hospital
Petoskey, Michigan 49770
United StatesSite Not Available
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota 55805
United StatesSite Not Available
North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesSite Not Available
Dartmouth Hitchcock Cardiology
Lebanon, New Hampshire 03756
United StatesSite Not Available
New York Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
WakeMed
Raleigh, North Carolina 27610
United StatesSite Not Available
Good Samaritan Hospital
Cincinnati, Ohio 45220
United StatesSite Not Available
Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesSite Not Available
North Ohio Research Elyria Memorial Hospital
Elyria, Ohio 44035
United StatesSite Not Available
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
The Pennsylvania State University Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United StatesSite Not Available
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Wellmont Holston Valley Medical Center
Kingsport, Tennessee 37660
United StatesSite Not Available
Baptist Memorial Hospital
Memphis, Tennessee 38120
United StatesSite Not Available
Methodist DeBakey Heart Center
Houston, Texas 77030-2767
United StatesSite Not Available
Scott & White Memorial Hospital
Temple, Texas 76508
United StatesSite Not Available
St. Peter Hospital
Olympia, Washington 98506
United StatesSite Not Available
Northwest Cardiovascular Research Institute-Spokane Cardiology
Spokane, Washington 99204
United StatesSite Not Available
Sacred Heart Medical Center
Spokane, Washington 99220
United StatesSite Not Available
Aurora St Lukes Medcial Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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