A Study to Evaluate Virtual Remote Control Robotic Percutaneous Coronary Intervention
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 19-007712
Sponsor Protocol Number: 19-007712
About this study
The purpose of this study is to evaluate whether or not robotic percutaneous coronary interventin (PCI) can be performed safely and effectively with the primary operator located in an adjacent control room using a remote control telecommunications system.
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:
- Adult patients (> 18 years old) undergoing elective planned percutaneous coronary intervention (PCI) of one coronary artery territory.
- Target coronary lesion is suitable for robotic PCI at discretion of the primary operator.
- Either femoral or radial approach planned for procedure.
- Patient must be able to tolerate dual antiplatelet therapy and give written informed consent.
Exclusion Criteria:
- Hemodynamic instability, cardiogenic shock or anticipated need for hemodynamic support device use.
- Severely calcified coronary lesion or anticipated need for rotational atherectomy.
- Chronic total occlusion.
- Unrevascularized multivessel coronary artery disease.
- Left ventricular ejection fraction < 35%.
- Advanced renal dysfunction (defined as GFR < 30 ml/min).
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 Mackram Eleid, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available