Thoraflex Hybrid and Relay Extension Post-Approval Study

Launched by VASCUTEK LTD. · Dec 5, 2022

Keywords

ClinConnect Summary

The Thoraflex Hybrid and Relay Extension Post-Approval Study is looking at how effective a medical device called the Thoraflex Hybrid is in treating certain serious conditions that affect the aorta, which is the main artery in the body. This study will also explore how well the Thoraflex Hybrid works when used together with another device called the RelayPro NBS stent-graft. Patients who are 18 years or older and are being treated with the Thoraflex Hybrid device, with the possibility of additional treatment using the RelayPro device, may be eligible to join the study.

If you participate, you can expect to have your treatment monitored over a period of 10 years, following standard medical care at the hospital where you receive treatment. To join, you need to give your consent and be able to attend regular check-ups. However, if you have certain medical or psychological conditions that may affect your ability to participate safely, you may not qualify for the study. This research aims to gather important information to help improve treatments for aortic diseases, benefiting future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.
• • Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.
• Exclusion Criteria:
• • Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.