Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Boston Scientific Corporation
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)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
