Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00287573

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 II Phase III

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

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
Estimated Study Completion Date:	April 2009
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Device: TAXUS Express2 Paclitaxel-Eluting Coronary Stent System
Arm 2: Active Comparator	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

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 Medical Center
Principal Investigator:	Stephen G. Ellis, MD	The Cleveland Clinic

More Information

Publications:

Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. Epub 2006 Mar 12.

Responsible Party:	Boston Scientific ( Kristan Tilton )
Study ID Numbers:	S5442, TAXUS V ISR
Study First Received:	February 3, 2006
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00287573 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Antimitotic Agents
Coronary Restenosis

Coronary Stenosis
Coronary Disease
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

Additional relevant MeSH terms:

Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Mitosis Modulators
Vascular Diseases
Antimitotic Agents
Coronary Restenosis

Coronary Stenosis
Pharmacologic Actions
Coronary Disease
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009