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