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

RecruitingNAAges 18 Years - anyAllLeMaitre Vascular
NCT05386342 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

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📋 Eligibility rules (as published)
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
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What it tests

  • TufTex Over-the-Wire Embolectomy Catheter
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Where

3 sites
Andrej Udelnow
Brandenburg, Germany
University Hospital Carl Gustav Carus TU Dresden
Dresden, Germany
Ospedale Regionale di Lugano - sede Civico
Lugano, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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