CAD, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DEVICERobotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
Sponsors
Corindus Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤ 80 years * Patients with STEMI\<12 h of symptom onset * Patient deemed appropriate for robotic-assisted PCI * The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
Exclusion criteria
Cardiogenic shock * Cardiac arrest * Need for manual or mechanical thrombectomy * Failure/inability/unwillingness to provide informed consent * The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System. | Procedure | Time measured from arrival to Cath Lab to device activation by CorPath GRX System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Medical Contact (FMC) to device activation time | Procedure | Time at which first patient evaluation. |
| Access to device activation | Procedure | Time measured from access sheath insertion to device activation by CorPath GRX System. |
| Access to wire time | Procedure | Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire. |
| Overall procedure time | Procedure | Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion. |
| Fluoroscopy time | Procedure | Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System. |
| Freedom from MACE events | 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. |
| Contrast fluid volume | Procedure | Total contrast volume (mL/cc) used during the procedure. |
| Conversion to manual (Binary) | Procedure | Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device. |
| Technical success | Procedure | Completion of the PCI procedure entirely robotically or with partial manual assistance. |
| Serious adverse events | 72-hours | All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized. |
| Patient radiation exposure | Procedure | DAP (dose-area-product) and AK (air kerma) as recorded during the procedure. |
Countries
United States
Outcome results
None listed