A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Corindus Inc.
- Enrollment
- 754
- Locations
- 16
- Primary Endpoint
- Number of Participants With Clinical Success
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 guidewires and stent/balloon catheters during PCI procedures.
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-procedure or hospital discharge, whichever occurs first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Number of Participants With Clinical Success
Time Frame: In-hospital (72-hours or discharge, whichever occurs first)
Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
Secondary Outcomes
- Number of Participants With In-hospital Major Adverse Coronary Events (MACE)(In-hospital (72-hours or discharge, whichever occurs first))
- Number of Participants With an Adverse Event(In-hospital (72-hours or discharge, whichever occurs first))