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

Recruiting now · Not applicable

Conditions studied: Thrombus, Embolus, Occlusion; Vessel

In brief

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

Key facts

Study ID

NCT05386342

Run by

LeMaitre Vascular

People needed

112

Starts

2023-01-11

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

Where it is running

• Andrej Udelnow — Brandenburg, Germany (enrolling)
• Ospedale Regionale di Lugano - sede Civico — Lugano, Switzerland (enrolling)
• University Hospital Carl Gustav Carus TU Dresden — Dresden, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.