A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

Launched by LEMAITRE VASCULAR · May 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the TufTex Over-the-Wire Embolectomy Catheter, which is used to remove blood clots (called emboli or thrombi) from blood vessels. The goal of the study is to confirm how well this catheter works and to ensure it is safe for patients undergoing procedures to treat these blockages. If you or a loved one is between the ages of 18 and 74, has been diagnosed with a blood clot, and is scheduled for surgery to remove it, you may be eligible to participate. Participants will need to give their consent and should not have certain health issues that might affect the study results.

If you join this study, you can expect to use the TufTex catheter during your scheduled treatment. The trial is currently recruiting participants, and everyone in the study will be monitored to help the researchers gather important information about the catheter's performance and safety. It's essential to know that pregnant or breastfeeding women, as well as those with certain health conditions, will not be able to participate in this study. Your participation could help improve future treatments for patients with similar conditions.

Gender

ALL

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 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