Confirming the safety and performance of a new embolectomy catheter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter in patients undergoing surgical procedures for the removal of arterial emboli and/or thrombi. It is a prospective, single-arm, post-market study that will collect clinical data to ensure the device's effectiveness and assess any emergent risks. The study will involve 112 patients across 3 to 8 sites in Europe, focusing on those who have not responded to thrombolytic therapy or for whom it is contraindicated.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female subject, ≥ 18 years of age at time of enrollment.
2. 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.
3. Subject signed an Informed Consent for participation.
4. Subject diagnosed with a embolus/thrombus.
5. Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion Criteria:

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

Where it's running

• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting
• Andrej Udelnow
  Brandenburg, Germany Recruiting
• Giorgio Prouse
  Lugano, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Giorgio Prouse — Ospedale Regionale di Lugano - sede Civico
• Study coordinator: Andrew Hodgkinson
• Email: ahodgkinson@lemaitre.com
• Phone: 781-425-1664

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.