Clinical trial NCT00301522: Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Stenosis
Keywords: Coronary
Artery
Stenosis
Drug-eluting
stent
restenosis
revascularization
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-13
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Incidence rate of TVR through 9 months post index procedure
timeFrame: 9 Months
Secondary outcomes:
measure: • 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).
timeFrame: 5 Years
measure: Stent thrombosis rate
timeFrame: 5 Years
measure: Target Vessel Failure
timeFrame: 5 Years
measure: Clinical procedural success and technical success
timeFrame: 5 years
measure: Binary restenosis rate.
timeFrame: 5 Years
measure: Absolute lesion length
timeFrame: 9 Months
measure: Reference Vessel Diameter (RVD)
timeFrame: 9 Months
measure: Minimum Lumen Diameter (MLD)
timeFrame: 9 Months
measure: Percent diameter stenosis (% DS)
timeFrame: 9 Months
measure: Acute gain
timeFrame: 9 Months
measure: Late loss
timeFrame: 9 Months
measure: Loss index
timeFrame: 9 Months
measure: Patterns of recurrent restenosis, including edge effect
timeFrame: 9 Months
measure: Coronary aneurysm
timeFrame: 9 Months
measure: Identification of potential safety issues, i.e., incomplete stent apposition.
timeFrame: 9 Months
measure: change in neointimal volume from post procedure to follow-up
timeFrame: 9 Months
measure: change in MLD within stent
timeFrame: 9 Months
measure: minimum lumen area (MLA) within stent
timeFrame: 9 Months
measure: lumen, plaque and vessel measurements at the stent edges (outside stent)
timeFrame: 9 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Birmingham
country: United States
facility: Cardiovascular Associates PC/Baptist Medical Center Montclair
state: Alabama
city: Birmingham
country: United States
facility: UAB Interventional Cardiology
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute and Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Memorial Hospital LaJolla
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Palm Beach Heart Research Institute, LLC
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Miami Beach
country: United States
facility: Miami International Cardiology Consultants
state: Florida
city: Ocala
country: United States
facility: Mediquest Research Group, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Safety Harbor
country: United States
facility: The Heart & Vascular Institute of Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Health Care
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Shawnee Mission
country: United States
facility: Shawnee Mission Medical Center
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St. John's Hospital and Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic/Saint Mary's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center/Capital Cardiovascular Associates
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology Research Division/Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: MidWest Cardiology Research Foundation/Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research, Ltd
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary's Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: South Austin Hospital/Capital Cardiovascular Specialists
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Hermann Hospital
state: Texas
city: Provo
country: United States
facility: Utah Valley Regional Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Columbia University
name: Gregg W. Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Stephen G. Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.