Terumo Aortic Global Endovascular Registry

Launched by VASCUTEK LTD. · Jan 27, 2020

Keywords

ClinConnect Summary

The Terumo Aortic Global Endovascular Registry is a research study aimed at collecting important information about the safety and effectiveness of specific medical devices called endovascular grafts. These grafts are used to treat conditions known as abdominal and thoracic aortic aneurysms, which are bulges in the main blood vessel that can be serious if not treated. This trial is currently looking for participants who are between the ages of 65 to 74 and meet certain criteria, such as needing surgery for their condition and being able to give their consent to take part in the study.

Participants in the trial can expect to have their health monitored closely over time to see how well the grafts work and to track any complications that may arise. It's important that those who join the study are willing to attend follow-up visits to ensure their safety and gather data for the research. If you're interested in participating or want more information, you should talk to your doctor, who can help determine if you meet the eligibility requirements and explain the study further. Your involvement could contribute to valuable insights that may improve treatment options for patients with aortic aneurysms in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Minimum age as per local regulations
• • Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
• • Ability to provide informed consent
• • o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment)
• • Willingness to comply with the registry protocol
• • Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.
• Exclusion Criteria:
• • • Patient is unable or unwilling to comply with the study follow-up regime.
• • Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure
• • Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)