Status:
RECRUITING
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
Lead Sponsor:
LeMaitre Vascular
Collaborating Sponsors:
Avania
Conditions:
Arterial Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial embol...
Detailed Description
This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in ...
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 arterial or venous emboli and/or thrombi, 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 comprised
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05386277
Start Date
January 11 2022
End Date
June 1 2027
Last Update
October 18 2024
Active Locations (3)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium
2
Andrej Udelnow
Brandenburg, Germany
3
Giorgio Prouse
Lugano, Switzerland