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Low enrollment and sponsor business decision
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI patients with clinical indication for primary PCI | Subjects with a clinical indication of STEMI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-PCI (CorPath GRX System) | Device | Robotic-PCI for acute ST elevation myocardial infarction (STEMI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72-hours |
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Inclusion Criteria:
Exclusion Criteria:
Cardiogenic shock
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Subjects with a clinical indication of STEMI.
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore F Mannino, DO, MA | WellStar Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15687141 | Background | 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. | |
| 19214981 |
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Data will be available 12 months after study completion.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2020 | Jul 1, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| First Medical Contact (FMC) to device activation time |
Time at which first patient evaluation. |
| Procedure |
| Access to device activation | Time measured from access sheath insertion to device activation by CorPath GRX System. | Procedure |
| Access to wire time | Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire. | Procedure |
| Overall procedure time | Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion. | Procedure |
| Fluoroscopy time | Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System. | Procedure |
| Patient radiation exposure | DAP (dose-area-product) and AK (air kerma) as recorded during the procedure. | Procedure |
| Contrast fluid volume | Total contrast volume (mL/cc) used during the procedure. | Procedure |
| Conversion to manual (Binary) | Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device. | Procedure |
| Technical success | Completion of the PCI procedure entirely robotically or with partial manual assistance. | Procedure |
| 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. | 72-hours |
| 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. |
| 22554637 | 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. |
| 20549683 | 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. |
| 23369556 | 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. |
| 28683937 | 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |