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Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis (TAXUS V ISR)

Primary Purpose

Coronary Restenosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAXUS Express2
Brachytherapy (beta source)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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% Exclusion Criteria: 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

Sites / Locations

  • Baptist Medical Center Princeton
  • Scripps Green Hospital
  • Mercy General Hospital
  • Stanford Medical Center
  • Aurora Denver Cardiology
  • Washington Hospital Center
  • Florida Hospital
  • Piedmont Hospital
  • Ochsner Clinic Foundation
  • Maine Medical Center
  • Washington Adventist Hospital
  • Tufts Medical Center
  • Lahey Clinic Hospital
  • University of Massachusetts Memorial Medical Center
  • Spectrum Health Hospitals
  • Cardiac & Vascular Research Center of Northern Michigan
  • Abbott Northwestern Hospital
  • Saint Luke's Hospital
  • Barnes Jewish Hospital
  • Nebraska Heart Institute
  • Albany Medical Center/Capital Cardiovascular Associates
  • Buffalo General Hospital
  • Columbia University Medical Center
  • Lenox Hill Hospital
  • Mid-Carolina Cardiology Research Division/Presbyterian Hospital
  • LeBauer Cardiovascular Research Foundation
  • Forsyth Medical Center
  • Wake Forest University Health Sciences
  • The Lindner Clinical Trial Center
  • Cleveland Clinic Foundation
  • North Ohio Research, Ltd
  • Oklahoma Cardiovascular Research Group
  • St. Mary's Medical Center
  • The Miriam Hospital
  • South Carolina Heart Center
  • St. Thomas Hospital
  • South Austin Hospital/Capital Cardiovascular Specialists
  • The Methodist Hospital Research Institute in Cardiovascular Interventions
  • University of Virginia
  • Swedish Medical Center
  • Sunnybrook & Women's College Health Sciences Centre
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Rate of Target Vessel Revascularization

Secondary Outcome Measures

Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE
Stent thrombosis rate
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).
Clinical procedural success and technical success
Binary restenosis rate
Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm
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
Identification of potential safety issues.
Change in neointimal volume from post procedure to follow-up
Change in MLD within the stent or area of brachytherapy
Minimum lumen area (MLA) within the stent or area of brachytherapy
Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)

Full Information

First Posted
February 3, 2006
Last Updated
August 5, 2010
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00287573
Brief Title
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Acronym
TAXUS V ISR
Official Title
A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.
Detailed Description
Percutaneous approaches to in-stent restenosis (ISR) have included balloon angioplasty alone, rotational atherectomy, cutting balloon angioplasty, directional coronary atherectomy, excimer laser angioplasty, placement of a second stent or any combination thereof, and intra-coronary brachytherapy. Of these, only brachytherapy has been shown to reduce recurrent restenosis after PCI for ISR, - and is now considered the standard of care. Logistical considerations in establishing and maintaining a radiation program have limited the widespread availability of this modality. These considerations include the need for involvement of radiation oncologists, physicists, and safety officers; nuclear licensing requirements; need for increased shielding and safety training; equipment and procedural complexities; as well as increased procedural time and costs. Furthermore, recurrent ISR after brachytherapy may still occur. Stent based drug delivery for the treatment of ISR holds promise as a much simpler, safer and potentially more effective alternative to brachytherapy. This is a prospective, randomized (1:1), open-label, multicenter, safety and efficacy trial for the treatment of in-stent restenosis. The primary objective is to demonstrate a superior or non-inferior 9-month target vessel revascularization (TVR) rate for TAXUS-SR stent compared to intra-coronary brachytherapy (beta source).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TAXUS Express2
Intervention Description
Paclitaxel-Eluting Coronary Stent System
Intervention Type
Procedure
Intervention Name(s)
Brachytherapy (beta source)
Intervention Description
Brachytherapy (beta source)
Primary Outcome Measure Information:
Title
Rate of Target Vessel Revascularization
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE
Time Frame
assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years
Title
Stent thrombosis rate
Time Frame
5 Years
Title
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).
Time Frame
5 Years
Title
Clinical procedural success and technical success
Time Frame
5 Years
Title
Binary restenosis rate
Time Frame
5 years
Title
Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm
Time Frame
5 Years
Title
Absolute lesion length
Time Frame
9 Months
Title
Reference Vessel Diameter (RVD)
Time Frame
9 Months
Title
Minimum Lumen Diameter (MLD)
Time Frame
9 Months
Title
Percent diameter stenosis (% DS)
Time Frame
9 Months
Title
Acute gain
Time Frame
9 Months
Title
Late loss
Time Frame
9 Months
Title
Loss index
Time Frame
9 Months
Title
Patterns of recurrent restenosis, including edge effect
Time Frame
9 Months
Title
Coronary aneurysm
Time Frame
9 Months
Title
Identification of potential safety issues.
Time Frame
9 Months
Title
Change in neointimal volume from post procedure to follow-up
Time Frame
9 Months
Title
Change in MLD within the stent or area of brachytherapy
Time Frame
9 Months
Title
Minimum lumen area (MLA) within the stent or area of brachytherapy
Time Frame
9 Months
Title
Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg W. Stone, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen G. Ellis, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Medical Center Princeton
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Scripps Green Hospital
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Stanford Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Aurora Denver Cardiology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912-6367
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Lahey Clinic Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Cardiac & Vascular Research Center of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1195
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Albany Medical Center/Capital Cardiovascular Associates
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mid-Carolina Cardiology Research Division/Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
North Ohio Research, Ltd
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
St. Mary's Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
South Austin Hospital/Capital Cardiovascular Specialists
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
The Methodist Hospital Research Institute in Cardiovascular Interventions
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Sunnybrook & Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16531618
Citation
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.
Results Reference
result

Learn more about this trial

Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

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