CorPath GRX STEMI Study

NCT04459299 | Terminated FDA Device

• 1 other identifier: 104-09062
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

STEMI - ST Elevation Myocardial Infarction; CAD

Outcome Measures

Primary Outcomes (1)

• Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.

  Time measured from arrival to Cath Lab to device activation by CorPath GRX System.

  Procedure

Secondary Outcomes (11)

• Freedom from MACE events

  72-hours

• First Medical Contact (FMC) to device activation time

  Procedure

• Access to device activation

  Procedure

• Access to wire time

  Procedure

• Overall procedure time

  Procedure

Study Arms (1)

STEMI patients with clinical indication for primary PCI

Subjects with a clinical indication of STEMI.

Device: Robotic-PCI (CorPath GRX System)

Interventions

Robotic-PCI (CorPath GRX System) DEVICE

Robotic-PCI for acute ST elevation myocardial infarction (STEMI).

STEMI patients with clinical indication for primary PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a clinical indication of STEMI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (1)

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Related Publications (6)

• 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.

  PMID: 15687141 BACKGROUND

• 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.

  PMID: 19214981 BACKGROUND

• 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.

  PMID: 22554637 BACKGROUND

• 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.

  PMID: 20549683 BACKGROUND

• 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.

  PMID: 23369556 BACKGROUND

• 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.

  PMID: 28683937 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Salvatore F Mannino, DO, MA

  WellStar Health System

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: September 28, 2020
• Primary Completion: November 26, 2020
• Study Completion: November 29, 2020
• Last Updated: December 20, 2023

Record last verified: 2022-01

Locations

US (1)