Confirming the safety and performance of TufTex Embolectomy Catheters

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 investigation is a prospective, single-arm, multicenter study designed to collect clinical data on the LeMaitre® TufTex Over-the-Wire Embolectomy Catheters. The study aims to confirm the device's effectiveness in removing arterial emboli and thrombi while assessing any emergent risks based on factual evidence. A total of 112 subjects scheduled for surgical treatment will be enrolled across four sites in three different countries, with an anticipated enrollment period of 48 months. Participants will be followed for one month post-procedure to evaluate outcomes.

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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised

Where it's running

• Andrej Udelnow
  Brandenburg, Germany Recruiting
• Ospedale Regionale di Lugano - sede Civico
  Lugano, Switzerland Recruiting
• University Hospital Carl Gustav Carus TU Dresden
  Dresden, Germany Not yet recruiting

Study contacts

• Principal investigator: Giorgio Prouse, MD — 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.