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

NCT ID: NCT00287573

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-01-31

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).

Conditions

Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

TAXUS Express2

Intervention Type: DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 2

Group Type: ACTIVE_COMPARATOR

Brachytherapy (beta source)

Intervention Type: PROCEDURE

Brachytherapy (beta source)

Interventions

TAXUS Express2

Paclitaxel-Eluting Coronary Stent System

Intervention Type: DEVICE

Brachytherapy (beta source)

Brachytherapy (beta source)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Boston Scientific

Principal Investigators

Gregg W. Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Stephen G. Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Baptist Medical Center Princeton

Birmingham, Alabama, United States

Scripps Green Hospital

La Jolla, California, United States

Mercy General Hospital

Sacramento, California, United States

Stanford Medical Center

Stanford, California, United States

Aurora Denver Cardiology

Aurora, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Florida Hospital

Orlando, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Lahey Clinic Hospital

Burlington, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Albany Medical Center/Capital Cardiovascular Associates

Albany, New York, United States

Buffalo General Hospital

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

Mid-Carolina Cardiology Research Division/Presbyterian Hospital

Charlotte, North Carolina, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

North Ohio Research, Ltd

Elyria, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

St. Mary's Medical Center

Langhorne, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

South Carolina Heart Center

Columbia, South Carolina, United States

St. Thomas Hospital

Nashville, Tennessee, United States

South Austin Hospital/Capital Cardiovascular Specialists

Austin, Texas, United States

The Methodist Hospital Research Institute in Cardiovascular Interventions

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.

Reference Type: RESULT

PMID: 16531618 (View on PubMed)

Other Identifiers

TAXUS V ISR

Identifier Type: -

Identifier Source: secondary_id

S5442

Identifier Type: -

Identifier Source: org_study_id