CorPath GRX STEMI Study

Browse trials for

• Myocardial Infarction 2,744
• ST Elevation Myocardial Infarction 666
• Infarction 2,563

Study population

Groups and cohorts

• STEMI patients with clinical indication for primary PCI

  Subjects with a clinical indication of STEMI.

  Device: Robotic-PCI (CorPath GRX System)

Interventions

• DeviceRobotic-PCI (CorPath GRX System)

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

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.

   Time frame: Procedure

Secondary outcomes

1. Freedom from MACE events

   Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis.

   Time frame: 72-hours

2. First Medical Contact (FMC) to device activation time

   Time at which first patient evaluation.

   Time frame: Procedure

3. Access to device activation

   Time measured from access sheath insertion to device activation by CorPath GRX System.

   Time frame: Procedure

4. Access to wire time

   Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.

   Time frame: Procedure

5. Overall procedure time

   Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.

   Time frame: Procedure

6. Fluoroscopy time

   Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.

   Time frame: Procedure

7. Patient radiation exposure

   DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.

   Time frame: Procedure

8. Contrast fluid volume

   Total contrast volume (mL/cc) used during the procedure.

   Time frame: Procedure

9. Conversion to manual (Binary)

   Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.

   Time frame: Procedure

10. Technical success

    Completion of the PCI procedure entirely robotically or with partial manual assistance.

    Time frame: Procedure

11. Serious adverse events

    All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.

    Time frame: 72-hours

Publications

• 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. PubMed 15687141 ↗
• 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. PubMed 19214981 ↗
• 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. PubMed 22554637 ↗
• 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. PubMed 20549683 ↗
• 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. PubMed 23369556 ↗
• 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. PubMed 28683937 ↗

Study documents

• Study protocol · Jun 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Data will be available 12 months after study completion.