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Not Yet Recruiting
NCT05634538
The ROB-OSTIAL Study
Conditions: Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 66
Sponsor: Corindus Inc.
Location: Italy
Summary
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices.
It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart.The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.
Eligibility Criteria
Inclusion Criteria:Male or nonpregnant female aged ≥18 yearsCoronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI)The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.Exclusion Criteria:Cardiogenic shock or hemodynamic instability requiring support.ST-elevation myocardial infarction.Ongoing acute renal failure.In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristicsMore than one lesion to be treatedOstial left main disease
Source: ClinicalTrials.gov (NCT05634538). StuddyBuddy aggregates publicly available trial information.