The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCap.
XLPAD is a CMS-approved Qualified Clinical Data Registry (QCDR)
Approximately 14,000 patients will be enrolled at approximately 20 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.
Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.
Principal Investigator
Dr. Nanjundappa's publications
Kennedy Adelman's publications
Biostatistician II
Biostatistician II
Independent data monitoring and clinical adjudication team
