Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Brief summary
The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.
Detailed description
This is prospective, dual-arm, randomized, multi-center, observational study comparing patient outcomes and staff radiation exposure in chronic total occlusion PCI procedures through 48 hours post procedure or hospital discharge, whichever occurs first.
Interventions
DEVICERobotic CTO PCI
Randomized to robotic CTO PCI.
PROCEDUREConventional (Manual) CTO PCI
Randomized to manual CTO PCI.
Sponsors
Corindus Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* CTO lesion, successfully crossed with conventional manual techniques; * The Investigator deems the procedure appropriate for robotic-assisted CTO PCI with the CorPath GRX System; * Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure; * The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion criteria
* Failure/inability/unwillingness to provide informed consent, or * Cardiogenic Shock; or * Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 48 hours | Defined as successful CTO PCI revascularization with achievement of \<30% residual diameter stenosis (visual estimate) within the treated segment and restoration of antegrade TIMI grade 3 flow, without in-hospital major adverse events (MAE). |
| In-hospital Major Adverse Events (MAE) | 48 hours | Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operator Radiation Exposure | Procedure | Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure. |
| Staff Radiation Exposure | Procedure | Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure. |
| Patient Radiation Exposure | Procedure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure |
| Fluoroscopy Time | Procedure | Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System. |
Countries
United States
Outcome results
None listed