NCT05386277

A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter

A Post Market Clinical Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: LeMaitre Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

Detailed description

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

Conditions

• Arterial Thromboembolism

Interventions

Type	Name	Description
DEVICE	TufTex Single Lumen Embolectomy Catheter	The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

Timeline

• Start date: 2022-01-11
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-05-23
• Last updated: 2024-10-18

Locations

3 sites across 3 countries: Belgium, Germany, Switzerland

Regulatory

• FDA-regulated device study