IRB Study Number 21-442
Status Recruiting
Phase Not Applicable
Institute Heart and Vascular Institute
Description
You may be eligible to participate in this observational research study if your doctor has decided to treat your peripheral vascular disease (PVD) with one or more Boston Scientific (BSC) drug-eluting devices. The purpose of this study is to collect data on the use of commercially approved BSC drug-eluting devices to understand how these devices are being used in a routine hospital setting to potentially improve patient outcomes in the future as well as to understand how the patient outcomes compare across diverse patient populations. The study data will also be used to continue to monitor the safety of these devices. The Boston Scientific device(s) are approved for commercial use in the US and throughout the world. Your doctor’s use of the device(s) to treat your medical condition is the standard of care at Cleveland Clinic. The study will collect data about the progress of your condition for up to 5 years after the initial treatment with the device(s). The treatment with the device(s), including the underlying procedure, is not considered part of the study.
Inclusion Criteria
Patients 18 years and older.
Written informed consent (patient data release-form). Use of any commercially available Boston Scientific drug-eluting device marketed for the treatment of lesions in the peripheral vasculature and specified in the Registry Enrollment Guide(s)
Exclusion Criteria
Life expectancy of < 1 year
