Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

NCT ID: NCT00301522

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-04-30

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)

Conditions

Coronary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Intervention Type: DEVICE

Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Arm 2

Group Type: ACTIVE_COMPARATOR

Express2

Intervention Type: DEVICE

Coronary Stent System

Interventions

TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Intervention Type: DEVICE

Express2

Coronary Stent System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Boston Scientific

Principal Investigators

Gregg W. Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Stephen G. Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Baptist Medical Center Princeton

Birmingham, Alabama, United States

Cardiovascular Associates PC/Baptist Medical Center Montclair

Birmingham, Alabama, United States

UAB Interventional Cardiology

Birmingham, Alabama, United States

Arizona Heart Institute and Hospital

Phoenix, Arizona, United States

Scripps Memorial Hospital LaJolla

La Jolla, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Stanford Medical Center

Stanford, California, United States

Aurora Denver Cardiology

Aurora, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Palm Beach Heart Research Institute, LLC

Atlantis, Florida, United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, United States

Miami International Cardiology Consultants

Miami Beach, Florida, United States

Mediquest Research Group, Inc.

Ocala, Florida, United States

Florida Hospital

Orlando, Florida, United States

The Heart & Vascular Institute of Florida

Safety Harbor, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Evanston Northwestern Health Care

Evanston, Illinois, United States

Midwest Heart Foundation

Lombard, Illinois, United States

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Lahey Clinic Hospital

Burlington, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

St. John's Hospital and Medical Center

Detroit, Michigan, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Mayo Clinic/Saint Mary's Hospital

Rochester, Minnesota, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Saint Michael's Medical Center

Newark, New Jersey, United States

Albany Medical Center/Capital Cardiovascular Associates

Albany, New York, United States

Buffalo General Hospital

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Mt. Sinai Medical Center

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Mid-Carolina Cardiology Research Division/Presbyterian Hospital

Charlotte, North Carolina, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Wake Heart Research

Raleigh, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MidWest Cardiology Research Foundation/Riverside Methodist Hospital

Columbus, Ohio, United States

North Ohio Research, Ltd

Elyria, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

St. Mary's Medical Center

Langhorne, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

South Carolina Heart Center

Columbia, South Carolina, United States

St. Thomas Hospital

Nashville, Tennessee, United States

South Austin Hospital/Capital Cardiovascular Specialists

Austin, Texas, United States

Cardiovascular Research Institute of Dallas

Dallas, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Texas Houston Hermann Hospital

Houston, Texas, United States

Utah Valley Regional Medical Center

Provo, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1215-23. doi: 10.1001/jama.294.10.1215.

Reference Type: RESULT

PMID: 16160130 (View on PubMed)

Wakabayashi K, Mintz GS, Weissman NJ, Stone GW, Ellis SG, Grube E, Ormiston JA, Turco MA, Pakala R, Xue Z, Desale S, Laynez-Carnicero A, Romaguera R, Sardi G, Pichard AD, Waksman R. Impact of drug-eluting stents on distal vessels. Circ Cardiovasc Interv. 2012 Apr;5(2):211-9. doi: 10.1161/CIRCINTERVENTIONS.111.965780. Epub 2012 Apr 10.

Reference Type: DERIVED

PMID: 22496083 (View on PubMed)

Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.

Reference Type: DERIVED

PMID: 20129555 (View on PubMed)

Other Identifiers

S5442

Identifier Type: -

Identifier Source: secondary_id

TAXUS V De novo

Identifier Type: -

Identifier Source: org_study_id