Status:
COMPLETED
PRECISION GRX Post-Market Study - Japan
Lead Sponsor:
Corindus Inc.
Collaborating Sponsors:
Japan Medicalnext, Co
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Brief 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 guide...
Detailed 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...
Eligibility Criteria
Inclusion
- Age ≥ 20 years;
- Patients with coronary artery disease with clinical indication for PCI;
- Patient deemed appropriate for robotic-assisted PCI; and
- 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
- Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or
- The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT03870087
Start Date
April 12 2019
End Date
October 9 2020
Last Update
October 19 2020
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan, 814-0001
2
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
3
Nayoro City General Hospital
Nayoro, Hokkaido, Japan, 096-8511
4
Iwate University Hospital
Morioka, Iwate, Japan, 020-0023