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

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00301522

Purpose

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

Condition	Intervention	Phase
Coronary Stenosis	Device: TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation Device: Express2	Phase II Phase III

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Incidence rate of TVR through 9 months post index procedure [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	1108
Study Start Date:	February 2003
Estimated Study Completion Date:	April 2009
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Device: TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation Paclitaxel-Eluting Coronary Stent, Slow-Formulation
Arm 2: Active Comparator	Device: Express2 Coronary Stent System

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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301522

Show 72 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Gregg W. Stone, MD	Columbia University Medical Center
Principal Investigator:	Stephen G. Ellis, MD	The Cleveland Clinic

More Information

Publications of Results:

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.

Responsible Party:	Boston Scientific ( Kristan Tilton )
Study ID Numbers:	TAXUS V De novo, S5442
Study First Received:	March 9, 2006
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00301522
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Coronary
Artery
Stenosis
Drug-eluting

stent
restenosis
revascularization

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia
Vascular Diseases

Constriction, Pathologic
Ischemia
Coronary Stenosis
Coronary Artery Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009