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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
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 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.
Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Germany
Andrej Udelnow
RECRUITING
Brandenburg
Switzerland
Giorgio Prouse
NOT_YET_RECRUITING
Lugano
Contact Information
Primary
Andrew Hodgkinson
ahodgkinson@lemaitre.com
781-425-1664
Backup
Brian Orrick
borrick@lemaitre.com
7814251685
Time Frame
Start Date: 2022-01-11
Estimated Completion Date: 2027-06
Participants
Target number of participants: 112
Treatments
Other: LeMaitre TufTex Single Lumen Embolectomy Catheter
The LeMaitre® Single Lumen Embolectomy Catheter is a catheter that consists of a natural latex rubber balloon secured with ligatures to a single lumen radiopaque shaft. When the balloon the emboli and/or thrombi can be removed by withdrawing the catheter tip through the arteriotomy.
Related Therapeutic Areas
Sponsors
Collaborators: Avania
Leads: LeMaitre Vascular