Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Ehtisham Mahmud

Description

Summary

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.

Official Title

A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions

Details

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.

Keywords

Coronary Artery Disease Myocardial Ischemia Coronary Disease Robotic-assisted PCI

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  • Candidates will be excluded from the study if any of the following conditions are present:
  • Failure/inability/unwillingness to provide informed consent; or
  • The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Locations

  • UC San Diego Health Sulpizio Cardiovascular Center accepting new patients
    San Diego California 92037 United States
  • Baylor Scott and White All Saints Medical Center accepting new patients
    Fort Worth Texas 76104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corindus Inc.
ID
NCT03278301
Lead Scientist
Ehtisham Mahmud
Study Type
Observational [Patient Registry]
Last Updated