NAVIGATE GRX Study

Corindus

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).

Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)

Study type

Observational

Funder types

Industry

Identifiers

NCT04883008

104-09466

Details and patient eligibility

About

The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.

Full description

This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.

Enrollment

50 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or nonpregnant female aged ≥ 20 years.
Patients with coronary artery disease with clinical indication for Percutaneous Coronary Intervention (PCI).
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.
In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics.
Acute STEMI within 72 hours pre-procedure.