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

Completed · Phase 2/Phase 3

Conditions studied: Coronary Restenosis

In brief

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.

Key facts

Study ID

NCT00287573

Run by

Boston Scientific Corporation

People needed

488

Starts

2003-06-01

Expected to finish

2010-01-01

Last updated by the study team

2010-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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