Status:
TERMINATED
CorPath GRX STEMI Study
Lead Sponsor:
Corindus Inc.
Conditions:
STEMI - ST Elevation Myocardial Infarction
CAD
Eligibility:
All Genders
18-80 years
Brief Summary
This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).
Detailed Description
This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction ...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤ 80 years
- Patients with STEMI\<12 h of symptom onset
- Patient deemed appropriate for robotic-assisted PCI
- The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
Exclusion
- Cardiogenic shock
- Cardiac arrest
- Need for manual or mechanical thrombectomy
- Failure/inability/unwillingness to provide informed consent
- The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment
Key Trial Info
Start Date :
September 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04459299
Start Date
September 28 2020
End Date
November 29 2020
Last Update
December 20 2023
Active Locations (1)
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1
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060