Status:
COMPLETED
Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions
Lead Sponsor:
Corindus Inc.
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
Brief Summary
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guide...
Detailed Description
This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-proced...
Eligibility Criteria
Inclusion
- Age \>18 years.
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
- The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion
- Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
- Failure/inability/unwillingness to provide informed consent.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT01917682
Start Date
August 1 2013
End Date
December 1 2016
Last Update
December 22 2020
Active Locations (16)
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1
UC San Diego Medical Center
San Diego, California, United States, 92103
2
Valley View Hospital
Glenwood Springs, Colorado, United States, 81601
3
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Orlando Regional Medical Center
Orlando, Florida, United States, 32806