Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
TAXUS V ISR
A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
2 other identifiers
interventional
488
2 countries
42
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
Longer than P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedAugust 6, 2010
August 1, 2010
1.5 years
February 3, 2006
August 5, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Target Vessel Revascularization
9 Months
Secondary Outcomes (20)
Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE
assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years
Stent thrombosis rate
5 Years
Target Vessel Failure (TVF, defined as any ischemia-driven revascularization of the target vessel, MI related to the target vessel, or death related to the target vessel).
5 Years
Clinical procedural success and technical success
5 Years
Binary restenosis rate
5 years
- +15 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Cumulative target lesion length is \</= 46 mm (visual estimate).
- Reference vessel diameter (RVD) is \>/= 2.5 and \</= 3.75 mm (visual estimate)
- Left ventricular ejection fraction (LVEF) is \>/= 25%
You may not qualify if:
- Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent in the target vessel. (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 non-target lesion interventions.)
- Previous or planned treatment with intra-coronary brachytherapy (gamma or beta source) in the target vessel
- Previous external radiotherapy to the heart or target vessel area
- Known genetic radiation sensitivity disorders (i.e. ataxia-telangiectasia, etc.)
- Side branch of the target lesion includes ostial narrowing \>/= 50% diameter stenosis (DS) and is \>/= 2.0 mm diameter
- Target lesion has been previously treated for ISR with the placement of a second stent(s), which covers \>/= 50% of the original stent length (a true "stent sandwich")
- Target vessel is pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, or transluminal extraction catheter immediately prior to delivery of randomized treatment (stent placement or intra-coronary brachytherapy)
- Recent myocardial infarction (MI) (symptom onset \</= 72 hours prior to randomization)
- CK-MB \>2x the local laboratory's upper limit of normal (ULN) (refers to a measured value on the day of the index procedure as drawn per protocol)
- Anticipated treatment with warfarin during any period in the 6 months post index procedure
- Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure
- Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Stanford Medical Center
Stanford, California, 94305, United States
Aurora Denver Cardiology
Aurora, Colorado, 80012, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Florida Hospital
Orlando, Florida, 32803, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912-6367, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Clinic Hospital
Burlington, Massachusetts, 01805, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407-1195, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Albany Medical Center/Capital Cardiovascular Associates
Albany, New York, 12208, United States
Buffalo General Hospital
Buffalo, New York, 14215, United States
Columbia University Medical Center
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Mid-Carolina Cardiology Research Division/Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
North Ohio Research, Ltd
Elyria, Ohio, 44035, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
St. Mary's Medical Center
Langhorne, Pennsylvania, 19047, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
St. Thomas Hospital
Nashville, Tennessee, 37205, United States
South Austin Hospital/Capital Cardiovascular Specialists
Austin, Texas, 78745, United States
The Methodist Hospital Research Institute in Cardiovascular Interventions
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.
PMID: 16531618RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregg W. Stone, MD
Columbia University
- PRINCIPAL INVESTIGATOR
Stephen G. Ellis, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 7, 2006
Study Start
June 1, 2003
Primary Completion
December 1, 2004
Study Completion
January 1, 2010
Last Updated
August 6, 2010
Record last verified: 2010-08