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

Recruiting now · Not applicable

Conditions studied: Arterial Thromboembolism

In brief

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

Key facts

Study ID

NCT05386277

Run by

LeMaitre Vascular

People needed

112

Starts

2022-01-11

Expected to finish

2027-06-01

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subject, ≥ 18 years of age at time of enrollment.
• Subject who is scheduled to undergo surgical treatment for the removal of arterial or venous emboli and/or thrombi, where one of the LeMaitre® Embolectomy Catheter will be used.
• Subject signed an Informed Consent for participation.
• Subject diagnosed with a embolus/thrombus.
• Subjects for whom thrombolytic therapy had failed or was contraindicated.

You may not qualify if…

• Co-morbidity that in the discretion of the investigator might confound the results.
• Subjects who are unable to read or write.
• Pregnant or lactating women at time of enrollment
• Subjects who are immune comprised

Where it is running

• Ziekenhuis Oost-Limburg — Genk, Belgium (enrolling)
• Andrej Udelnow — Brandenburg, Germany (enrolling)
• Giorgio Prouse — Lugano, Switzerland

Full record on ClinicalTrials.gov

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