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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00287573
First received: February 3, 2006
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Coronary Restenosis
Device: TAXUS Express2
Procedure: Brachytherapy (beta source)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 488
Study Start Date: June 2003
Study Completion Date: January 2010
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Device: TAXUS Express2
Paclitaxel-Eluting Coronary Stent System
Active Comparator: Arm 2 Procedure: Brachytherapy (beta source)
Brachytherapy (beta source)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287573

  Show 42 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Gregg W. Stone, MD Columbia University
Principal Investigator: Stephen G. Ellis, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: Marcie Clarkin, Boston Scientific
ClinicalTrials.gov Identifier: NCT00287573     History of Changes
Other Study ID Numbers: S5442, TAXUS V ISR
Study First Received: February 3, 2006
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014