Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  • 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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Ervin Mazniku
emazniku@montefiore.org

More Details

NCT ID
NCT03278301
Status
Recruiting
Sponsor
Corindus Inc.

Study Contact

Tina Ridgeway, BS, RN
508-653-3335
tina.ridgeway@corindus.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.