Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Information source: Boston Scientific Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Restenosis
Intervention: TAXUS Express2 (Device); Brachytherapy (beta source) (Procedure)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Boston Scientific Corporation Official(s) and/or principal investigator(s): Gregg W. Stone, MD, Principal Investigator, Affiliation: Columbia University Stephen G. Ellis, MD, Principal Investigator, Affiliation: The Cleveland Clinic
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.
Clinical Details
Official title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Rate of Target Vessel Revascularization
Secondary outcome: Incidence of composite major adverse cardiac events (MACE) and the individual components of MACEStent 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)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Baptist Medical Center Princeton, Birmingham, Alabama 35211, United States
Scripps Green Hospital, LaJolla, 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, 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
Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada
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
Additional Information
Starting date: June 2003
Last updated: August 5, 2010
|