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

NCT00301522 | Completed Phase 2

• 2 other identifiers: TAXUS V De novoS5442
• Study Type: interventional
• Target: 1,108
• Locations: 1 country
• Sites: 72

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

Conditions

Coronary Stenosis

Keywords

Coronary; Artery; Stenosis; Drug-eluting; stent; restenosis; revascularization

Outcome Measures

Primary Outcomes (1)

• Incidence rate of TVR through 9 months post index procedure

  9 Months

Secondary Outcomes (19)

• • 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

• Stent thrombosis rate

  5 Years

• Target Vessel Failure

  5 Years

• Clinical procedural success and technical success

  5 years

• Binary restenosis rate.

  5 Years

Study Arms (2)

Arm 1

EXPERIMENTAL

Device: TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Arm 2

ACTIVE COMPARATOR

Device: Express2

Interventions

TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation DEVICE

Paclitaxel-Eluting Coronary Stent, Slow-Formulation

Arm 1

Express2 DEVICE

Coronary Stent System

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (72)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

Cardiovascular Associates PC/Baptist Medical Center Montclair

Birmingham, Alabama, 35213, United States

Location

UAB Interventional Cardiology

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Institute and Hospital

Phoenix, Arizona, 85006, United States

Location

Scripps Memorial Hospital LaJolla

La Jolla, California, 92037, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Stanford Medical Center

Stanford, California, 94305, United States

Location

Aurora Denver Cardiology

Aurora, Colorado, 80012, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Palm Beach Heart Research Institute, LLC

Atlantis, Florida, 33462, United States

Location

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756, United States

Location

Miami International Cardiology Consultants

Miami Beach, Florida, 33137, United States

Location

Mediquest Research Group, Inc.

Ocala, Florida, 34471, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

The Heart & Vascular Institute of Florida

Safety Harbor, Florida, 34695, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Shawnee Mission Medical Center

Shawnee Mission, Kansas, 66204, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

St. John's Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic/Saint Mary's Hospital

Rochester, Minnesota, 55902, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Albany Medical Center/Capital Cardiovascular Associates

Albany, New York, 12208, United States

Location

Buffalo General Hospital

Buffalo, New York, 14215, United States

Location

Columbia University Medical Center

New York, New York, 10021, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Rochester General Hospital

Rochester, New York, 14641, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Mid-Carolina Cardiology Research Division/Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Wake Heart Research

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MidWest Cardiology Research Foundation/Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

North Ohio Research, Ltd

Elyria, Ohio, 44035, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

St. Mary's Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

South Austin Hospital/Capital Cardiovascular Specialists

Austin, Texas, 78745, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Texas Houston Hermann Hospital

Houston, Texas, 77030, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (3)

• 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.

  PMID: 16160130 RESULT

• 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.

  PMID: 22496083 DERIVED

• 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.

  PMID: 20129555 DERIVED

MeSH Terms

Conditions

Coronary Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregg W. Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Stephen G. Ellis, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: February 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: April 1, 2009
• Last Updated: August 6, 2010

Record last verified: 2010-08

Locations

US (72)