Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004876
Sponsor Protocol Number: 2013-001
About this study
The purpose of this registry is to collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age > 18 years
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system
- The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
Exclusion Criteria
- Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry
- concurrent participation in another registry is not an automatic exclusion criterion for this study
- Failure/inability/unwillingness to provide informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Rajiv Gulati, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available