Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2020-09-28
2020-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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STEMI patients with clinical indication for primary PCI
Subjects with a clinical indication of STEMI.
Robotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
Interventions
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Robotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Salvatore F Mannino, DO, MA
Role: STUDY_CHAIR
WellStar Health System
Locations
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Wellstar Kennestone Hospital
Marietta, Georgia, United States
Countries
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References
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Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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104-09062
Identifier Type: -
Identifier Source: org_study_id