The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions
The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing or Quantitative Coronary Angiography (QCA) severity of restenosis. Secondary endpoints include the following: * Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure). * Stent thrombosis rate. * TVF. * Clinical procedural success and technical success. * Binary restenosis rate. * Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include: * 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 * IVUS Substudy * Identification of potential safety issues, i.e., incomplete stent apposition. * change in neointimal volume from post procedure to follow-up * change in MLD within stent * minimum lumen area (MLA) within stent * lumen, plaque and vessel measurements at the stent edges (outside stent)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,108
Paclitaxel-Eluting Coronary Stent, Slow-Formulation
Coronary Stent System
Incidence rate of TVR through 9 months post index procedure
Time frame: 9 Months
• Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).
Time frame: 5 Years
Stent thrombosis rate
Time frame: 5 Years
Target Vessel Failure
Time frame: 5 Years
Clinical procedural success and technical success
Time frame: 5 years
Binary restenosis rate.
Time frame: 5 Years
Absolute lesion length
Time frame: 9 Months
Reference Vessel Diameter (RVD)
Time frame: 9 Months
Minimum Lumen Diameter (MLD)
Time frame: 9 Months
Percent diameter stenosis (% DS)
Time frame: 9 Months
Acute gain
Time frame: 9 Months
Late loss
Time frame: 9 Months
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Cardiovascular Associates PC/Baptist Medical Center Montclair
Birmingham, Alabama, United States
UAB Interventional Cardiology
Birmingham, Alabama, United States
Arizona Heart Institute and Hospital
Phoenix, Arizona, United States
Scripps Memorial Hospital LaJolla
La Jolla, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Mercy General Hospital
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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
...and 62 more locations
Loss index
Time frame: 9 Months
Patterns of recurrent restenosis, including edge effect
Time frame: 9 Months
Coronary aneurysm
Time frame: 9 Months
Identification of potential safety issues, i.e., incomplete stent apposition.
Time frame: 9 Months
change in neointimal volume from post procedure to follow-up
Time frame: 9 Months
change in MLD within stent
Time frame: 9 Months
minimum lumen area (MLA) within stent
Time frame: 9 Months
lumen, plaque and vessel measurements at the stent edges (outside stent)
Time frame: 9 Months