Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis (TAXUS V ISR)
Coronary Restenosis
About this trial
This is an interventional treatment trial for Coronary Restenosis
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
Sites / Locations
- Baptist Medical Center Princeton
- Scripps Green Hospital
- Mercy General Hospital
- Stanford Medical Center
- Aurora Denver Cardiology
- Washington Hospital Center
- Florida Hospital
- Piedmont Hospital
- Ochsner Clinic Foundation
- Maine Medical Center
- Washington Adventist Hospital
- Tufts Medical Center
- Lahey Clinic Hospital
- University of Massachusetts Memorial Medical Center
- Spectrum Health Hospitals
- Cardiac & Vascular Research Center of Northern Michigan
- Abbott Northwestern Hospital
- Saint Luke's Hospital
- Barnes Jewish Hospital
- Nebraska Heart Institute
- Albany Medical Center/Capital Cardiovascular Associates
- Buffalo General Hospital
- Columbia University Medical Center
- Lenox Hill Hospital
- Mid-Carolina Cardiology Research Division/Presbyterian Hospital
- LeBauer Cardiovascular Research Foundation
- Forsyth Medical Center
- Wake Forest University Health Sciences
- The Lindner Clinical Trial Center
- Cleveland Clinic Foundation
- North Ohio Research, Ltd
- Oklahoma Cardiovascular Research Group
- St. Mary's Medical Center
- The Miriam Hospital
- South Carolina Heart Center
- St. Thomas Hospital
- South Austin Hospital/Capital Cardiovascular Specialists
- The Methodist Hospital Research Institute in Cardiovascular Interventions
- University of Virginia
- Swedish Medical Center
- Sunnybrook & Women's College Health Sciences Centre
- Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm 1
Arm 2