A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Andrej Udelnow
RECRUITING
Brandenburg
University Hospital Carl Gustav Carus TU Dresden
NOT_YET_RECRUITING
Dresden
Switzerland
Ospedale Regionale di Lugano - sede Civico
RECRUITING
Lugano
Contact Information
Primary
Andrew Hodgkinson
ahodgkinson@lemaitre.com
781-425-1664
Backup
Brian Orrick
borrick@lemaitre.com
781-425-1685
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2027-06
Participants
Target number of participants: 112
Treatments
Other: LeMaitre TufTex Over-the-Wire Embolectomy Catheter
The LeMaitre Over the Wire Embolectomy Catherer is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
Related Therapeutic Areas
Sponsors
Collaborators: Avania
Leads: LeMaitre Vascular