Cardiac Cath Lab Staff Radiation Exposure

NCT03959072 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2023-02-02

No results posted yet for this study

Summary

The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.

Conditions

Interventions

DEVICE

Robotic CTO PCI

Randomized to robotic CTO PCI.

PROCEDURE

Conventional (Manual) CTO PCI

Randomized to manual CTO PCI.

Sponsors & Collaborators

  • Corindus Inc.

    lead INDUSTRY

Principal Investigators

  • William Lombardi (Acting), MD · University of Washington

  • William Nicholson (Emeritus), MD · WellSpan York Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2021-09-14
Completion
2021-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959072 on ClinicalTrials.gov