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
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.
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
Single group
TufTex Single Lumen Embolectomy Catheter
DeviceThe SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure
The primary safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure and 1 Month post index procedure.
Performance objective is the technical success as defined as <30% residual stenosis
The primary performance objective is the technical success as defined as \<30% residual stenosis of the target vessel.
1. Clinical success
Clinical success is target vessel dependent and defined as; (1) The absence of target vessel limb amputation post-intervention in case of limb cloths, and 2. successful dialysis sessions performed post-intervention in case of dialysis shunt revascularization (2) Revision rate is defined as the number of patients with target vessel reintervention (3) Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency. (4) Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.
2. Revision Rate
Revision rate is defined as the number of patients with target vessel reintervention
3. Primary Assisted Patency
Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency.
4. Secondary Patency
Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.
Exploratory endpoints
Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention.
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LeMaitre Vascular
Lead sponsor
Avania
Collaborator
