TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00292474
First received: February 14, 2006
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

The ultimate goal of a paclitaxel eluting stent system (TAXUS stent) is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has taken place.

The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent under controlled trial circumstances used in the treatment of new coronary artery lesions (heart blockages) This clinical investigation will evaluate the safety and effectiveness of the TAXUS Stent with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier system for treatment of new coronary artery lesions.


Condition Intervention Phase
Coronary Artery Disease
Device: percutaneous coronary intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate the safety and effectiveness of the TAXUS Stent System with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier syst

Secondary Outcome Measures:
  • Secondary endpoints include the following:
  • • Rates of composite MACE and the individual components of MACE (MI, TVR, Cardiac Death), assessed at 1, 4 and 9 months after the index procedure and annually for 5 more years (i.e., 1, 2, 3, 4, and 5 years after the index procedure).
  • • Stent thrombosis rate
  • • Target Vessel Failure
  • • Clinical procedural success
  • • Binary restenosis rate

Enrollment: 1326
Study Start Date: March 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAXUS Express Device: percutaneous coronary intervention
Placebo Comparator: Express Bare Device: percutaneous coronary intervention

Detailed Description:

This was a prospective randomized, double-blind, multicenter safety and efficacy trial. Patients were stratified by presence or absence of medically treated diabetes mellitus and vessel diameter (<3.0 mm or >/=3.0 mm), then randomized 1:1 to receive either the TAXUS Stent or a Control stent. Additional study stents were permitted to optimize outcomes. The study was considered complete (with regard to the primary endpoint) after all patients enrolled had completed the 9 month follow-up.

Enrollment of 1172 patients was planned; 1326 were treated and randomized at 73 centers involving 76 sites by 8 July 2002 with 667 in the TAXUS group and 659 in the Control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is > or = 18 years old
  2. Eligible for percutaneous coronary intervention (PCI)
  3. Documented stable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  4. Left ventricular ejection fraction (LVEF) of > or = 25%
  5. Acceptable candidate for CABG
  6. Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  7. Willing to comply with all specified follow-up evaluations

1. Target lesion located within a single native coronary vessel 2. Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by one (1) study stent 3. Cumulative target lesion length is > or = 10 mm and < or = 28 mm (visual estimate) 4. RVD of > or = 2.5mm to < or = 3.75 mm (visual estimate) 5. Target lesion diameter stenosis > or = 50% (visual estimate) 6. Target lesion is de novo (i.e., a coronary lesion not previously treated)

7. Target lesion located within a single native coronary vessel 8. Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by one (1) study stent 9. Cumulative target lesion length is > or = 10 mm and < or = 28 mm (visual estimate) 10. RVD of > or = 2.5mm to < or = 3.75 mm (visual estimate) 11. Target lesion diameter stenosis > or = 50% (visual estimate) 12. Target lesion is de novo (i.e., a coronary lesion not previously treated)

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Exclusion Criteria:

1. Known sensitivity to paclitaxel 2. Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent. (Note: previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as the procedure with the non-study stent meets the protocol defined criteria for staged procedures) 3. Previous or planned treatment with intravascular brachytherapy in the target vessel 4. MI within 72 hours prior to the index procedure and/or CK-MB >2x the local laboratory's upper limits of normal (refers to a measured value on the day of the index procedure) 5. Cerebrovascular Accident (CVA) within the past 6 months 6. Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L) 7. Contraindication to ASA, or to both clopidogrel and ticlopidine 8. Leukopenia (leukocyte count <3.5 x 109/liter) 9. Thrombocytopenia (platelet count <100,000/mm3) 10. Active peptic ulcer or active gastrointestinal (GI) bleeding 11. Known allergy to stainless steel 12. Any prior true anaphylactic reaction to contrast agents 13. Known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure 14. Patient is currently taking colchicine 15. Patient is currently, or has been treated with paclitaxel within 12 months of the index procedure 16. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study 17. Life expectancy of less than 24 months due to other medical conditions 18. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study 19. 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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292474

Locations
United States, Ohio
Stephen G.Ellis
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Gregg W Stone, MD Columbia Hospital
Principal Investigator: Stephen G Ellis, MD The Cleveland Clinic
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristan Tilton, Boston Scientific
ClinicalTrials.gov Identifier: NCT00292474     History of Changes
Other Study ID Numbers: S2004, TAXUS IV
Study First Received: February 14, 2006
Last Updated: October 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
coronary artery disease
percutaneous coronary interventions
stent implant
drug-coated stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014