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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287573
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : August 6, 2010
Information provided by:
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Restenosis Device: TAXUS Express2 Procedure: Brachytherapy (beta source) Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study Start Date : June 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: Arm 1 Device: TAXUS Express2
Paclitaxel-Eluting Coronary Stent System

Active Comparator: Arm 2 Procedure: Brachytherapy (beta source)
Brachytherapy (beta source)

Primary Outcome Measures :
  1. Rate of Target Vessel Revascularization [ Time Frame: 9 Months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Stent thrombosis rate [ Time Frame: 5 Years ]
  3. 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 ]
  4. Clinical procedural success and technical success [ Time Frame: 5 Years ]
  5. Binary restenosis rate [ Time Frame: 5 years ]
  6. Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm [ Time Frame: 5 Years ]
  7. Absolute lesion length [ Time Frame: 9 Months ]
  8. Reference Vessel Diameter (RVD) [ Time Frame: 9 Months ]
  9. Minimum Lumen Diameter (MLD) [ Time Frame: 9 Months ]
  10. Percent diameter stenosis (% DS) [ Time Frame: 9 Months ]
  11. Acute gain [ Time Frame: 9 Months ]
  12. Late loss [ Time Frame: 9 Months ]
  13. Loss index [ Time Frame: 9 Months ]
  14. Patterns of recurrent restenosis, including edge effect [ Time Frame: 9 Months ]
  15. Coronary aneurysm [ Time Frame: 9 Months ]
  16. Identification of potential safety issues. [ Time Frame: 9 Months ]
  17. Change in neointimal volume from post procedure to follow-up [ Time Frame: 9 Months ]
  18. Change in MLD within the stent or area of brachytherapy [ Time Frame: 9 Months ]
  19. Minimum lumen area (MLA) within the stent or area of brachytherapy [ Time Frame: 9 Months ]
  20. Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy) [ Time Frame: 9 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287573

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Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Gregg W. Stone, MD Columbia University
Principal Investigator: Stephen G. Ellis, MD The Cleveland Clinic
Publications of Results:
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Responsible Party: Marcie Clarkin, Boston Scientific Identifier: NCT00287573    
Other Study ID Numbers: S5442
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases