Confirming the safety and performance of TufTex Embolectomy Catheters
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
This study is testing a new type of catheter to see if it safely and effectively removes blood clots from arteries in people who are having surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LeMaitre Vascular Industry-sponsored |
| Locations | 3 sites (Brandenburg and 2 other locations) |
| Trial ID | NCT05386342 on ClinicalTrials.gov |
What this trial studies
This clinical investigation is a prospective, single-arm, multicenter study designed to collect clinical data on the LeMaitre® TufTex Over-the-Wire Embolectomy Catheters. The study aims to confirm the device's effectiveness in removing arterial emboli and thrombi while assessing any emergent risks based on factual evidence. A total of 112 subjects scheduled for surgical treatment will be enrolled across four sites in three different countries, with an anticipated enrollment period of 48 months. Participants will be followed for one month post-procedure to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for surgical removal of emboli or thrombi using the TufTex Embolectomy Catheter.
Not a fit: Patients with co-morbidities that may confound results or those who are immune compromised 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 blockages.
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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised
Where this trial is running
Brandenburg and 2 other locations
- Andrej Udelnow — Brandenburg, Germany (Recruiting)
- University Hospital Carl Gustav Carus TU Dresden — Dresden, Germany (Not_yet_recruiting)
- Ospedale Regionale di Lugano - sede Civico — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Giorgio Prouse, MD — 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.