Status:
RECRUITING
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
Lead Sponsor:
LeMaitre Vascular
Collaborating Sponsors:
Avania
Conditions:
Thrombus
Embolus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
Detailed Description
This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) Embolectomy Catheters and to c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05386342
Start Date
January 11 2023
End Date
June 1 2027
Last Update
October 18 2024
Active Locations (3)
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1
Andrej Udelnow
Brandenburg, Germany
2
University Hospital Carl Gustav Carus TU Dresden
Dresden, Germany
3
Ospedale Regionale di Lugano - sede Civico
Lugano, Switzerland