Study to Confirm the Safety and Performance of the LeMaitre TufTex Over-the-Wire Embolectomy Catheter for Removing Arterial Emboli and Thrombi During Surgery

What this Trial Is About

This clinical investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire OTW Embolectomy Catheters. The study aims to confirm the devices performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters