Confirming the safety and performance of a new 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
NA · LeMaitre Vascular · NCT05386277
This study is testing a new catheter to see if it safely and effectively helps patients who need surgery to remove blood clots when other treatments haven't worked for them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LeMaitre Vascular (industry) |
| Locations | 3 sites (Genk and 2 other locations) |
| Trial ID | NCT05386277 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter in patients undergoing surgical procedures for the removal of arterial emboli and/or thrombi. It is a prospective, single-arm, post-market study that will collect clinical data to ensure the device's effectiveness and assess any emergent risks. The study will involve 112 patients across 3 to 8 sites in Europe, focusing on those who have not responded to thrombolytic therapy or for whom it is contraindicated.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for surgical treatment of arterial or venous emboli and/or thrombi who will use the LeMaitre® Embolectomy Catheter.
Not a fit: Patients with co-morbidities that may confound results, those unable to read or write, pregnant or lactating women, and immunocompromised individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of embolectomy procedures for patients with arterial thromboembolism.
How similar studies have performed: Other studies have shown success with similar embolectomy devices, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genk and 2 other locations
- Ziekenhuis Oost-Limburg — Genk, Belgium (RECRUITING)
- Andrej Udelnow — Brandenburg, Germany (RECRUITING)
- Giorgio Prouse — Lugano, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Giorgio Prouse — Ospedale Regionale di Lugano - sede Civico
- Study coordinator: Andrew Hodgkinson
- Email: ahodgkinson@lemaitre.com
- Phone: 781-425-1664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arterial Thromboembolism