Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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) or use of a Legally Authorized Representative (LAR). - 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Thoracic - TEVAR
  • Device: Thoracic
    Implant of a Relay stent graft system
Abdominal - EVAR
  • Device: Abdominal
    Implant with an Anaconda or Treo Stent graft system
Custom Device
  • Device: Custom Device
    Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Other indications Isolated Iliac Artery Aneurysm (IIAA)
  • Device: Illiac Artery
    Implant with an Anaconda Iliac leg only

Recruiting Locations

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Vascutek Ltd.

Study Contact

Michelle Durnan
+44 141 343 0195
m.durnan@terumoaortic.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.