Actively Recruiting
Study to Confirm Safety and Performance of the LeMaitre TufTex Single Lumen Embolectomy Catheter for Removing Arterial Emboli and Thrombi during Surgery
Led by LeMaitre Vascular · Updated on 2024-10-18
112
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This clinical trial evaluates the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in patients undergoing surgery to remove arterial emboli and thrombi. The study aims to confirm the devices performance and safety, identify any new risks based on real patient data, and ensure the benefit-risk balance remains acceptable. Sponsored by LeMaitre4 Vascular, Inc., the study is conducted at several sites in Europe with a planned enrollment of 112 patients. Participants will receive treatment using the LeMaitre4 TufTex Single Lumen Embolectomy Catheter, a device featuring a latex balloon attached to a radiopaque shaft. The balloon helps remove emboli and thrombi by being withdrawn through an artery during surgery. This is a single-arm study, meaning all participants receive the device treatment without comparison groups. During the study, researchers will monitor safety outcomes such as device- or procedure-related serious events during and up to one month after the procedure. They will also assess technical success based on the amount of artery narrowing after one month. Additional evaluations include clinical success, revision rates, and artery openness over time. Participants will be followed for at least one month after treatment to track these outcomes and ensure safety.
CONDITIONS
Brief Title
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
Research Team
A
Andrew Hodgkinson
B
Brian Orrick
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
