CorPath GRX STEMI Study (TREAT) (TREAT)
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|ClinicalTrials.gov Identifier: NCT04459299|
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment|
|STEMI - ST Elevation Myocardial Infarction CAD||Procedure: Robotic-PCI (CorPath GRX System)|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 5, 2021|
STEMI patients with clinical indication for primary PCI
Subjects with a clinical indication of STEMI.
Procedure: Robotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
- Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System. [ Time Frame: Procedure ]Time measured from arrival to Cath Lab to device activation by CorPath GRX System.
- Freedom from MACE events [ Time Frame: 72-hours ]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.
- First Medical Contact (FMC) to device activation time [ Time Frame: Procedure ]Time at which first patient evaluation.
- Access to device activation [ Time Frame: Procedure ]Time measured from access sheath insertion to device activation by CorPath GRX System.
- Access to wire time [ Time Frame: Procedure ]Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.
- Overall procedure time [ Time Frame: Procedure ]Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.
- Fluoroscopy time [ Time Frame: Procedure ]Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.
- Patient radiation exposure [ Time Frame: Procedure ]DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.
- Contrast fluid volume [ Time Frame: Procedure ]Total contrast volume (mL/cc) used during the procedure.
- Conversion to manual (Binary) [ Time Frame: Procedure ]Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.
- Technical success [ Time Frame: Procedure ]Completion of the PCI procedure entirely robotically or with partial manual assistance.
- Serious adverse events [ Time Frame: 72-hours ]All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459299
|Contact: Tina Ridgeway, BS, RNemail@example.com|
|Contact: John Van Vleet, MSfirstname.lastname@example.org|
|Study Chair:||Salvatore F Mannino, DO, MA||WellStar Health System|