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

Information source: Boston Scientific Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Restenosis

Intervention: TAXUS Express2 (Device); Brachytherapy (beta source) (Procedure)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Boston Scientific Corporation

Official(s) and/or principal investigator(s):
Gregg W. Stone, MD, Principal Investigator, Affiliation: Columbia University
Stephen G. Ellis, MD, Principal Investigator, Affiliation: The Cleveland Clinic

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.

Clinical Details

Official title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of Target Vessel Revascularization

Secondary outcome:

Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE

Stent thrombosis rate

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).

Clinical procedural success and technical success

Binary restenosis rate

Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm

Absolute lesion length

Reference Vessel Diameter (RVD)

Minimum Lumen Diameter (MLD)

Percent diameter stenosis (% DS)

Acute gain

Late loss

Loss index

Patterns of recurrent restenosis, including edge effect

Coronary aneurysm

Identification of potential safety issues.

Change in neointimal volume from post procedure to follow-up

Change in MLD within the stent or area of brachytherapy

Minimum lumen area (MLA) within the stent or area of brachytherapy

Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cumulative target lesion length is

- Reference vessel diameter (RVD) is >/= 2. 5 and

- 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

- 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

Locations and Contacts

Baptist Medical Center Princeton, Birmingham, Alabama 35211, United States

Scripps Green Hospital, LaJolla, California 92037, United States

Mercy General Hospital, Sacramento, California 95819, United States

Stanford Medical Center, Stanford, California 94305, United States

Aurora Denver Cardiology, Aurora, Colorado 80012, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

Florida Hospital, Orlando, Florida 32803, United States

Piedmont Hospital, Atlanta, Georgia 30309, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Maine Medical Center, Portland, Maine 04102, United States

Washington Adventist Hospital, Takoma Park, Maryland 20912-6367, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

Lahey Clinic Hospital, Burlington, Massachusetts 01805, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

Spectrum Health Hospitals, Grand Rapids, Michigan 49503, United States

Cardiac & Vascular Research Center of Northern Michigan, Petoskey, Michigan 49770, United States

Abbott Northwestern Hospital, Minneapolis, Minnesota 55407-1195, United States

Saint Luke's Hospital, Kansas City, Missouri 64111, United States

Barnes Jewish Hospital, St. Louis, Missouri 63110, United States

Nebraska Heart Institute, Lincoln, Nebraska 68526, United States

Albany Medical Center/Capital Cardiovascular Associates, Albany, New York 12208, United States

Buffalo General Hospital, Buffalo, New York 14215, United States

Columbia University Medical Center, New York, New York 10021, United States

Lenox Hill Hospital, New York, New York 10021, United States

Mid-Carolina Cardiology Research Division/Presbyterian Hospital, Charlotte, North Carolina 28204, United States

LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina 27401, United States

Forsyth Medical Center, Winston-Salem, North Carolina 27103, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

North Ohio Research, Ltd, Elyria, Ohio 44035, United States

Oklahoma Cardiovascular Research Group, Oklahoma City, Oklahoma 73120, United States

Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

St. Mary's Medical Center, Langhorne, Pennsylvania 19047, United States

The Miriam Hospital, Providence, Rhode Island 02906, United States

South Carolina Heart Center, Columbia, South Carolina 29204, United States

St. Thomas Hospital, Nashville, Tennessee 37205, United States

South Austin Hospital/Capital Cardiovascular Specialists, Austin, Texas 78745, United States

The Methodist Hospital Research Institute in Cardiovascular Interventions, Houston, Texas 77030, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Swedish Medical Center, Seattle, Washington 98104, United States

Additional Information

Starting date: June 2003
Last updated: August 5, 2010

Page last updated: August 23, 2015

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