Coronary Restenosis
Conditions
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 description
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).
Interventions
DEVICETAXUS Express2
Paclitaxel-Eluting Coronary Stent System
PROCEDUREBrachytherapy (beta source)
Brachytherapy (beta source)
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cumulative target lesion length is \</= 46 mm (visual estimate). * Reference vessel diameter (RVD) is \>/= 2.5 and \</= 3.75 mm (visual estimate) * Left ventricular ejection fraction (LVEF) is \>/= 25%
Exclusion criteria
* Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent in the target vessel. (Note:previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as, the procedure with the non-study stent meets the protocol defined criteria for non-target lesion interventions.) * Previous or planned treatment with intra-coronary brachytherapy (gamma or beta source) in the target vessel * Previous external radiotherapy to the heart or target vessel area * Known genetic radiation sensitivity disorders (i.e. ataxia-telangiectasia, etc.) * Side branch of the target lesion includes ostial narrowing \>/= 50% diameter stenosis (DS) and is \>/= 2.0 mm diameter * Target lesion has been previously treated for ISR with the placement of a second stent(s), which covers \>/= 50% of the original stent length (a true stent sandwich) * Target vessel is pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, or transluminal extraction catheter immediately prior to delivery of randomized treatment (stent placement or intra-coronary brachytherapy) * Recent myocardial infarction (MI) (symptom onset \</= 72 hours prior to randomization) * CK-MB \>2x the local laboratory's upper limit of normal (ULN) (refers to a measured value on the day of the index procedure as drawn per protocol) * Anticipated treatment with warfarin during any period in the 6 months post index procedure * Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure * Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Target Vessel Revascularization | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| Stent thrombosis rate | 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). | 5 Years |
| Clinical procedural success and technical success | 5 Years |
| Binary restenosis rate | 5 years |
| Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm | 5 Years |
| Absolute lesion length | 9 Months |
| Reference Vessel Diameter (RVD) | 9 Months |
| Minimum Lumen Diameter (MLD) | 9 Months |
| Percent diameter stenosis (% DS) | 9 Months |
| 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 |
| Late loss | 9 Months |
| Loss index | 9 Months |
| Patterns of recurrent restenosis, including edge effect | 9 Months |
| Coronary aneurysm | 9 Months |
| Identification of potential safety issues. | 9 Months |
| Change in neointimal volume from post procedure to follow-up | 9 Months |
| Change in MLD within the stent or area of brachytherapy | 9 Months |
| Minimum lumen area (MLA) within the stent or area of brachytherapy | 9 Months |
| Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy) | 9 Months |
| Acute gain | 9 Months |
Countries
Canada, United States
Outcome results
None listed