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
Sponsor: LeMaitre Vascular + Avania
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure
Time frame: During procedure and 1 month post index procedure
Performance objective is the technical success as defined as <30% residual stenosis
Time frame: 1 month post index procedure
Secondary Endpoints
1. Clinical success
2. Revision Rate
3. Primary Assisted Patency
Eligibility Criteria
Inclusion Criteria: 1. Male and female subject, ≥ 18 years of age at time of enrollment. 2. 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. 3. Subject signed an Informed Consent for participation. 4. Subject diagnosed with a embolus/thrombus. 5. Subjects for whom thrombolytic therapy had failed or was contraindicated. Exclusion Criteria: 1. Co-morbidity that in the discretion of the investigator might confound the results. 2. Subjects who are unable to read or write. 3. Pregnant or lactating women at time of enrollment 4. Subjects who are immune comprised
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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