PRECISION GRX Registry
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|ClinicalTrials.gov Identifier: NCT03278301|
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: Robotic-assisted PCI|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||3 Days|
|Official Title:||A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions|
|Actual Study Start Date :||August 27, 2017|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
- Device: Robotic-assisted PCI
The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
- Clinical Success [ Time Frame: Discharge or 72 hours post intervention, whichever comes first. ]Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
- Technical Success [ Time Frame: Procedure ]Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
- Overall Procedure Time [ Time Frame: Procedure ]Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
- PCI Procedure Time [ Time Frame: Procedure ]Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
- Fluoroscopy Time [ Time Frame: Procedure ]Total Fluoroscopy Time during procedure will be captured.
- Patient Radiation Exposure [ Time Frame: Procedure ]DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
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): NCT03278301
|Contact: Christopoher Cain, BSN||508-653-3335 ext firstname.lastname@example.org|
|United States, Texas|
|The Heart Hospital Baylor Plano||Recruiting|
|Plano, Texas, United States, 75093|
|Contact: Srinivasa Potluri, MD|
|Principal Investigator:||Ehtisham Mahmud, MD||University of California, San Diego|