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

Coronary Stenosis Clinical Trial

Official title:

TAXUS V: De Novo Lesion: A Randomized, Double-blind Trial to Assess TAXUS Paclitaxel-Eluting Coronary Stents, SR Formulation, in the Treatment of De Novo Coronary Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301522
• Other study ID #: TAXUS V De novo
• Secondary ID: S5442
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 9, 2006
• Last updated: August 5, 2010
• Start date: February 2003
• Est. completion date: April 2009

Study information

• Verified date: August 2010
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 1108
• Est. completion date: April 2009
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation
Paclitaxel-Eluting Coronary Stent, Slow-Formulation
• Express2
Coronary Stent System

Locations

Country	Name	City	State
United States	Albany Medical Center/Capital Cardiovascular Associates	Albany	New York
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Palm Beach Heart Research Institute, LLC	Atlantis	Florida
United States	Aurora Denver Cardiology	Aurora	Colorado
United States	South Austin Hospital/Capital Cardiovascular Specialists	Austin	Texas
United States	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	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Buffalo General Hospital	Buffalo	New York
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Mid-Carolina Cardiology Research Division/Presbyterian Hospital	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Clearwater Cardiovascular and Interventional Consultants	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	South Carolina Heart Center	Columbia	South Carolina
United States	MidWest Cardiology Research Foundation/Riverside Methodist Hospital	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Cardiovascular Research Institute of Dallas	Dallas	Texas
United States	St. John's Hospital and Medical Center	Detroit	Michigan
United States	North Ohio Research, Ltd	Elyria	Ohio
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Texas Houston Hermann Hospital	Houston	Texas
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Scripps Memorial Hospital LaJolla	La Jolla	California
United States	St. Mary's Medical Center	Langhorne	Pennsylvania
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Midwest Heart Foundation	Lombard	Illinois
United States	Miami International Cardiology Consultants	Miami Beach	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Mediquest Research Group, Inc.	Ocala	Florida
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Arizona Heart Institute and Hospital	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Utah Valley Regional Medical Center	Provo	Utah
United States	Wake Heart Research	Raleigh	North Carolina
United States	Mayo Clinic/Saint Mary's Hospital	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	University of California Davis Medical Center	Sacramento	California
United States	The Heart & Vascular Institute of Florida	Safety Harbor	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	Stanford Medical Center	Stanford	California
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 comp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of TVR through 9 months post index procedure		9 Months	Yes
Secondary	• 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	Yes
Secondary	Stent thrombosis rate		5 Years	Yes
Secondary	Target Vessel Failure		5 Years	Yes
Secondary	Clinical procedural success and technical success		5 years	Yes
Secondary	Binary restenosis rate.		5 Years	Yes
Secondary	Absolute lesion length		9 Months	No
Secondary	Reference Vessel Diameter (RVD)		9 Months	No
Secondary	Minimum Lumen Diameter (MLD)		9 Months	No
Secondary	Percent diameter stenosis (% DS)		9 Months	No
Secondary	Acute gain		9 Months	Yes
Secondary	Late loss		9 Months	No
Secondary	Loss index		9 Months	No
Secondary	Patterns of recurrent restenosis, including edge effect		9 Months	Yes
Secondary	Coronary aneurysm		9 Months	Yes
Secondary	Identification of potential safety issues, i.e., incomplete stent apposition.		9 Months	Yes
Secondary	change in neointimal volume from post procedure to follow-up		9 Months	Yes
Secondary	change in MLD within stent		9 Months	Yes
Secondary	minimum lumen area (MLA) within stent		9 Months	Yes
Secondary	lumen, plaque and vessel measurements at the stent edges (outside stent)		9 Months	Yes