PRECISION GRX Registry

Corindus

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Robotic-assisted PCI

Study type: Observational

Funder types: Industry

Identifiers

NCT03278301

2017-001

Details and patient eligibility

About

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Full description

This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Enrollment: 952 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Candidates will be included in the study only if all of the following conditions are met:

1. Age ≥18 years;
2. Patients with coronary artery disease with clinical indication for PCI;
3. Patient deemed appropriate for robotic-assisted PCI; and
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

• Candidates will be excluded from the study if any of the following conditions are present:

  1. Failure/inability/unwillingness to provide informed consent; or
  2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.