A Phase 2/3 interventional study of TAXUS Express2 and Brachytherapy (beta source) in Coronary Restenosis, sponsored by Boston Scientific Corporation. Completed at 42 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-06.
Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment
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).
97 studies on the registry are indexed under Coronary Restenosis; 9 are open to participants now.
This study's enrollment of 488 is above the median of 240 across 59 interventional studies indexed under Coronary Restenosis.
Browse Coronary Restenosis studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: TAXUS Express2
Procedure: Brachytherapy (beta source)
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
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
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation