N/A
N=754
Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions
Coronary Artery Disease · Coronary Disease · Myocardial Ischemia · Heart Diseases · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01917682 ↗Enrolled (actual)
754
Serious AEs
2.4%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Clinical Success — 723 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CorPath-assisted Percutaneous Coronary Intervention (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corindus Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success |
723 | — |
| SECONDARY Number of Participants With In-hospital Major Adverse Coronary Events (MACE) |
6 | — |
| SECONDARY Number of Participants With an Adverse Event |
18 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01917682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.