A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeMaitre Vascular
About this trial
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- TufTex Over-the-Wire Embolectomy Catheter
Treatment groups
112 Participants
are divided into 1 treatment groupSponsors and collaborators
LeMaitre Vascular
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov