Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
- Conditions
- Coronary Restenosis
- Interventions
- Device: TAXUS Express2Procedure: Brachytherapy (beta source)
- Registration Number
- NCT00287573
- Lead Sponsor
- Boston Scientific Corporation
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 488
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 TAXUS Express2 - Arm 2 Brachytherapy (beta source) -
- Primary Outcome Measures
Name Time Method Rate of Target Vessel Revascularization 9 Months
- Secondary Outcome Measures
Name Time Method 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 Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm 5 Years Absolute lesion length 9 Months Reference Vessel Diameter (RVD) 9 Months Minimum Lumen Diameter (MLD) 9 Months Percent diameter stenosis (% DS) 9 Months Acute gain 9 Months Late loss 9 Months Loss index 9 Months Patterns of recurrent restenosis, including edge effect 9 Months Coronary aneurysm 9 Months Identification of potential safety issues. 9 Months Change in neointimal volume from post procedure to follow-up 9 Months Change in MLD within the stent or area of brachytherapy 9 Months Minimum lumen area (MLA) within the stent or area of brachytherapy 9 Months Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy) 9 Months
Trial Locations
- Locations (42)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Sunnybrook & Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Scripps Green Hospital
🇺🇸LaJolla, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Mid-Carolina Cardiology Research Division/Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
Barnes Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
North Ohio Research, Ltd
🇺🇸Elyria, Ohio, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Albany Medical Center/Capital Cardiovascular Associates
🇺🇸Albany, New York, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
Aurora Denver Cardiology
🇺🇸Aurora, Colorado, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
The Methodist Hospital Research Institute in Cardiovascular Interventions
🇺🇸Houston, Texas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
St. Mary's Medical Center
🇺🇸Langhorne, Pennsylvania, United States
South Austin Hospital/Capital Cardiovascular Specialists
🇺🇸Austin, Texas, United States
Stanford Medical Center
🇺🇸Stanford, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States