Clinical Trial: Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
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 Summary:
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).
Sponsor: Boston Scientific Corporation
Current Primary Outcome: Rate of Target Vessel Revascularization [ Time Frame: 9 Months ]
Original Primary Outcome: Rate of Target Vessel Revascularization through 9 months post index procedure
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- • 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 (i.e., 1, 2, 3, 4 and 5 years post index procedure)
- • 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
- • Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include:
- - 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
- • IVUS Substudy
- - 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)
Information By: Boston Scientific Corporation
Dates:
Date Received: February 3, 2006
Date Started: June 2003
Date Completion:
Last Updated: August 5, 2010
Last Verified: August 2010