Terumo Aortic Global Endovascular Registry (TiGER)

Vascutek

Status: Enrolling

Conditions: Surgery; Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm

Treatments: Device: Abdominal; Device: Custom Device; Device: Thoracic; Device: Illiac Artery

Study type: Observational

Funder types: Industry

Identifiers

NCT04246463

TiGER-001

Details and patient eligibility

About

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Full description

Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 4 patient groups

Thoracic - TEVAR

Treatment:

Device: Thoracic

Abdominal - EVAR

Treatment:

Device: Abdominal

Custom Device

Treatment:

Device: Custom Device

Other indications

Description:

Isolated Iliac Artery Aneurysm (IIAA)

Treatment:

Device: Illiac Artery