A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
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 Emboli and/or Thrombi
LeMaitre Vascular
112 participants
Jan 11, 2022
INTERVENTIONAL
Conditions
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 emboli and/or thrombi
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05386277