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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
488
Paclitaxel-Eluting Coronary Stent System
Brachytherapy (beta source)
Rate of Target Vessel Revascularization
Time frame: 9 Months
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
Stent thrombosis rate
Time frame: 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).
Time frame: 5 Years
Clinical procedural success and technical success
Time frame: 5 Years
Binary restenosis rate
Time frame: 5 years
Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm
Time frame: 5 Years
Absolute lesion length
Time frame: 9 Months
Reference Vessel Diameter (RVD)
Time frame: 9 Months
Minimum Lumen Diameter (MLD)
Time frame: 9 Months
Percent diameter stenosis (% DS)
Time frame: 9 Months
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Scripps Green Hospital
La Jolla, California, United States
Mercy General Hospital
Sacramento, California, United States
Stanford Medical Center
Stanford, California, United States
Aurora Denver Cardiology
Aurora, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
...and 32 more locations
Acute gain
Time frame: 9 Months
Late loss
Time frame: 9 Months
Loss index
Time frame: 9 Months
Patterns of recurrent restenosis, including edge effect
Time frame: 9 Months
Coronary aneurysm
Time frame: 9 Months
Identification of potential safety issues.
Time frame: 9 Months
Change in neointimal volume from post procedure to follow-up
Time frame: 9 Months
Change in MLD within the stent or area of brachytherapy
Time frame: 9 Months
Minimum lumen area (MLA) within the stent or area of brachytherapy
Time frame: 9 Months
Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)
Time frame: 9 Months