PRECISION GRX Post-Market Study - Japan

Corindus

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Robotic-assisted PCI

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03870087

104-08185

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 in the first 231 patients treated with the CorPath device in Japan.

Full description

This is a single-arm, open-label, multi-center patient registry in Japan 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: 242 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 20 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, unless the EC has waived informed consent.

Exclusion criteria

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

Trial design

242 participants in 1 patient group

Robotic PCI

Description:

All subjects treated with CorPath GRX during the PCI procedure.

Treatment:

Device: Robotic-assisted PCI