Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis (TAXUS V ISR)

• Rate of Target Vessel Revascularization [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  

• 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 ] [ Designated as safety issue: Yes ]
  
• Stent thrombosis rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  
• 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 ] [ Designated as safety issue: Yes ]
  
• Clinical procedural success and technical success [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  
• Binary restenosis rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  
• Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  
• Absolute lesion length [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  
• Reference Vessel Diameter (RVD) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  
• Minimum Lumen Diameter (MLD) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  
• Percent diameter stenosis (% DS) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Acute gain [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Late loss [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  
• Loss index [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  
• Patterns of recurrent restenosis, including edge effect [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Coronary aneurysm [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Identification of potential safety issues. [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Change in neointimal volume from post procedure to follow-up [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Change in MLD within the stent or area of brachytherapy [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Minimum lumen area (MLA) within the stent or area of brachytherapy [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  
• Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  

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).