N/A
N=12
PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02373852 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure — 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Saphenous vein graft (SVG) stenting (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gardia Medical
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure |
5 | — |
| PRIMARY Number of Patients That Undergo Successful SVG Procedure |
12 | — |
Summary
The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).
Eligibility Criteria
Inclusion Criteria
- Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.
- Patient is greater than or equal to 18 years of age.
Exclusion Criteria
- Undergone cardiac surgery in the past 60 days before the procedure.
Data sourced from ClinicalTrials.gov (NCT02373852). 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.