Clinical trial NCT04459299: CorPath GRX STEMI Study
Official title: An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: STEMI - ST Elevation Myocardial Infarction
CAD
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a clinical indication of STEMI.

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 (STEMI).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.
timeFrame: Procedure
Secondary outcomes:
measure: Freedom from MACE events
timeFrame: 72-hours
measure: First Medical Contact (FMC) to device activation time
timeFrame: Procedure
measure: Access to device activation
timeFrame: Procedure
measure: Access to wire time
timeFrame: Procedure
measure: Overall procedure time
timeFrame: Procedure
measure: Fluoroscopy time
timeFrame: Procedure
measure: Patient radiation exposure
timeFrame: Procedure
measure: Contrast fluid volume
timeFrame: Procedure
measure: Conversion to manual (Binary)
timeFrame: Procedure
measure: Technical success
timeFrame: Procedure
measure: Serious adverse events
timeFrame: 72-hours
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
Study officials:
affiliation: WellStar Health System
name: Salvatore F Mannino, DO, MA
role: STUDY_CHAIR
References:
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citation: Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.
citation: Miller DL, Schueler BA, Balter S; National Council on Radiation Protection and Measurements; International Commission on Radiological Protection. New recommendations for occupational radiation protection. J Am Coll Radiol. 2012 May;9(5):366-8. doi: 10.1016/j.jacr.2012.02.006. No abstract available.
citation: Ciraj-Bjelac O, Rehani MM, Sim KH, Liew HB, Vano E, Kleiman NJ. Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern? Catheter Cardiovasc Interv. 2010 Nov 15;76(6):826-34. doi: 10.1002/ccd.22670.
citation: Vano E, Kleiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013 Feb;24(2):197-204. doi: 10.1016/j.jvir.2012.10.016. Epub 2013 Jan 28.
citation: Mahmud E, Naghi J, Ang L, Harrison J, Behnamfar O, Pourdjabbar A, Reeves R, Patel M. Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2017 Jul 10;10(13):1320-1327. doi: 10.1016/j.jcin.2017.03.050.