Stenosis Clinical Trial
Official title:
Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
NCT number | NCT02373852 |
Other study ID # | SVG-CL003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | June 2016 |
Verified date | August 2019 |
Source | Gardia Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 12 |
Est. completion date | June 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Bnai Zion | Haifa |
Lead Sponsor | Collaborator |
---|---|
Gardia Medical |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure | Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days. | 30 Days | |
Primary | Number of Patients That Undergo Successful SVG Procedure | Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred. | 30 Days |
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