Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
- Conditions
- Coronary Stenosis
- Interventions
- Device: TAXUS Paclitaxel-Eluting Coronary Stent, Slow-FormulationDevice: Express2
- Registration Number
- NCT00301522
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions
- Detailed Description
The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing or Quantitative Coronary Angiography (QCA) severity of restenosis.
Secondary endpoints include the following:
* Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).
* Stent thrombosis rate.
* TVF.
* Clinical procedural success and technical success.
* Binary restenosis rate.
* Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include:
* Absolute lesion length
* Reference Vessel Diameter (RVD)
* Minimum Lumen Diameter (MLD)
* Percent diameter stenosis (% DS)
* Acute gain
* Late loss
* Loss index
* Patterns of recurrent restenosis, including edge effect
* Coronary aneurysm
* IVUS Substudy
* Identification of potential safety issues, i.e., incomplete stent apposition.
* change in neointimal volume from post procedure to follow-up
* change in MLD within stent
* minimum lumen area (MLA) within stent
* lumen, plaque and vessel measurements at the stent edges (outside stent)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1108
- Patient was ≥ 18 years old.
- Eligible for percutaneous coronary intervention.
- Documented stable angina pectoris.
- LVEF of greater than 25%.
- Acceptable candidate for coronary artery bypass grafting.
- Target lesion segment is located within a single native coronary vessel.
- Target lesion was de novo.
- RVD was greater than 2.25 mm and less than 4.0 mm .and patient and/or lesion fulfilled protocol defined subgroups.
- Cumulative target lesion length was greater than 10 mm and less than 46mm assessed after pre-dilatation with standard balloon or cutting balloon angioplasty, including adjacent areas of dissection that were covered.
- Target lesion diameter stenosis less than 50% before pre-dilatation .
- Vessel and lesion morphology such that the lesion was treated only with study stent(s); no planned use of commercial stents.
- Known hypersensitivity to paclitaxel.
- Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
- Planned use of both the study stent and a non-study stent in the treatment of the target vessel.
- Previous or planned treatment with intravascular brachytherapy in the target vessel.
- Recent MI.
- CK-MB greater than 2x the local laboratory's upper limit of normal.
- Cerebrovascular accident within 6 months of randomization.
- Planned CABG ≤ 9 months post index procedure.
- Acute or chronic renal dysfunction.
- Leukopenia.
- Thrombocytopenia or thrombocytosis.
- Active peptic ulcer or active gastrointestinal bleeding, or previously active within 6 months.
- Known allergy to stainless steel.
- Any prior true anaphylactic reaction to contrast agents.
- Contraindication to ASA or to both clopidogrel and ticlopidine.
- Patient was on warfarin or it was anticipated that treatment with warfarin would have been required during any period within 6 months post the index procedure.
- Patient was or had been treated with chemotherapeutic agents within 12 months of the index procedure.
- Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure.
- Male or female with known intention to procreate within 3 months post index procedure.
- Co-morbid condition(s) that could limit the patient's ability to participate in the study, limit compliance with follow-up requirements or impact the scientific integrity of the study.
- Planned surgical procedure requiring withdrawal of any anti-platelet therapy within 6 months post index procedure.
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- Unprotected left main coronary artery disease.
- Target lesion was ostial in location.
- Target lesion and/or target vessel proximal to the target lesion was moderately or severely calcified.
- Target lesion was located within or distal to a > 60° bend in the vessel.
- Side branch of the target lesion included ostial narrowing ≥ 50% DS and was ≥ 2.0 mm diameter.
- Target lesion was totally occluded.
- Angiographic presence of probable or definite thrombus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation - Arm 2 Express2 -
- Primary Outcome Measures
Name Time Method Incidence rate of TVR through 9 months post index procedure 9 Months
- Secondary Outcome Measures
Name Time Method lumen, plaque and vessel measurements at the stent edges (outside stent) 9 Months Minimum Lumen Diameter (MLD) 9 Months Loss index 9 Months Patterns of recurrent restenosis, including edge effect 9 Months Stent thrombosis rate 5 Years Clinical procedural success and technical success 5 years Reference Vessel Diameter (RVD) 9 Months Target Vessel Failure 5 Years Binary restenosis rate. 5 Years Percent diameter stenosis (% DS) 9 Months Acute gain 9 Months Coronary aneurysm 9 Months change in neointimal volume from post procedure to follow-up 9 Months • Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure). 5 Years Absolute lesion length 9 Months change in MLD within stent 9 Months Late loss 9 Months minimum lumen area (MLA) within stent 9 Months Identification of potential safety issues, i.e., incomplete stent apposition. 9 Months
Trial Locations
- Locations (72)
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
MidWest Cardiology Research Foundation/Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
St. Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Clearwater Cardiovascular and Interventional Consultants
🇺🇸Clearwater, Florida, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Evanston Northwestern Health Care
🇺🇸Evanston, Illinois, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Barnes Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Cardiovascular Research Institute of Dallas
🇺🇸Dallas, Texas, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas Houston Hermann Hospital
🇺🇸Houston, Texas, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
Cardiovascular Associates PC/Baptist Medical Center Montclair
🇺🇸Birmingham, Alabama, United States
Arizona Heart Institute and Hospital
🇺🇸Phoenix, Arizona, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Mayo Clinic/Saint Mary's Hospital
🇺🇸Rochester, Minnesota, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Denver Cardiology
🇺🇸Aurora, Colorado, United States
South Austin Hospital/Capital Cardiovascular Specialists
🇺🇸Austin, Texas, United States
UAB Interventional Cardiology
🇺🇸Birmingham, Alabama, United States
Scripps Memorial Hospital LaJolla
🇺🇸La Jolla, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Stanford Medical Center
🇺🇸Stanford, California, United States
Palm Beach Heart Research Institute, LLC
🇺🇸Atlantis, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
The Heart & Vascular Institute of Florida
🇺🇸Safety Harbor, Florida, United States
Miami International Cardiology Consultants
🇺🇸Miami Beach, Florida, United States
Mediquest Research Group, Inc.
🇺🇸Ocala, Florida, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Albany Medical Center/Capital Cardiovascular Associates
🇺🇸Albany, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Mid-Carolina Cardiology Research Division/Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Wake Heart Research
🇺🇸Raleigh, North Carolina, United States
North Ohio Research, Ltd
🇺🇸Elyria, Ohio, United States
St. Mary's Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Utah Valley Regional Medical Center
🇺🇸Provo, Utah, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States