Actively Recruiting
A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Led by Vascutek Ltd. · Updated on 2026-03-13
1000
Participants Needed
58
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vascutek Ltd.
Lead Sponsor
B
Bolton Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are observing the safety and performance of Terumo Aortic endovascular grafts used to treat patients with aortic aneurysms and other related conditions during routine clinical practice. This global, multi-center registry collects real-world data to better understand outcomes after these devices have been approved and are in use. The study is open label and includes multiple groups based on the type of aneurysm or device implanted. Participants receive one of several types of Terumo Aortic endovascular stent-grafts, including Thoracic Relay stent grafts, Abdominal Anaconda or Treo grafts, custom fenestrated devices, and Iliac artery-specific implants. These devices are CE marked or custom-made and are implanted following standard clinical procedures. The registry tracks patients treated with these devices in usual care settings without altering treatment. During the study, participants will attend follow-up visits where researchers collect safety data, patient-reported outcomes, and health economic information. Key outcomes measured include aortic-related mortality within 30 days post-implant, technical success on the day of surgery, and composite clinical success and additional endpoints at one year. The registry aims to monitor long-term performance and safety of these grafts in real-world use, with participation lasting as determined by follow-up schedules.
CONDITIONS
Brief Title
Terumo Aortic Global Endovascular Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age as per local regulations
- Indication for aortic endovascular repair with an approved or custom Terumo Aortic graft
- Ability to provide informed consent
- Emergent cases allowed if consent is obtained after intervention or by Legally Authorized Representative
- Willingness to comply with the registry protocol
- Willingness to attend follow-up visits
- Patients in the TREO registry may have data migrated with approval and reconsent
You will not qualify if you...
- Unable or unwilling to comply with study follow-up
- Contraindicated per device instructions for use
- Any medical, social, or psychological problem preventing treatment or study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants receive an implant of a Terumo Aortic endovascular stent-graft device as part of standard clinical practice.
1 visit (in-person) for the implant procedure
Duration - Up to 1 year or longer
Participants are observed for safety, device performance, and clinical outcomes after the implant.
Follow-up visits as per routine clinical care, typically including visits at 30 days and 1 year post-implant
Trial Site Locations
Total: 58 locations
1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Actively Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
UC Health Memorial Hospital Center
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Loyola University of Chicago (Loyola)
Chicago, Illinois, United States, 60153
Actively Recruiting
8
Ascension St. Vincent Heart Center
Indianapolis, Indiana, United States, 46260
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
13
Ascension Texas Cardiovascular / UT Dell Medical School
Austin, Texas, United States, 78705
Actively Recruiting
14
Baylor, Scott & White Health (BSW Health)
Texas City, Texas, United States, 75093
Actively Recruiting
15
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
16
University of Virgina
Charlottesville, Virginia, United States, 22908
Actively Recruiting
17
Sentara Heart Hospital
Norfolk, Virginia, United States, 22042
Actively Recruiting
18
Imeldaziekenhuis
Bonheiden, Belgium
Actively Recruiting
19
Clinques Uni. St Lucs
Brussels, Belgium
Withdrawn
20
Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
Bron, France
Actively Recruiting
21
CHU St Etienne
Saint-Etienne, France
Actively Recruiting
22
Klinikum Augsburg
Augsburg, Germany
Actively Recruiting
23
Evangelisches Krankenhaus Hubertus
Berlin, Germany
Actively Recruiting
24
Klinikum Chemnitz
Chemnitz, Germany
Actively Recruiting
25
University Heart Center Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
26
Aortic Center University Hospital
Göttingen, Germany
Withdrawn
27
Bonifatius Hospital
Lingen, Germany
Actively Recruiting
28
St. Franziskus Hospital
Münster, Germany
Actively Recruiting
29
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
30
Policlinico Consorziale di Bari
Bari, Italy
Actively Recruiting
31
Compensorio Sanitario Bolzano
Bolzano, Italy
Actively Recruiting
32
Cagliari-Ospedale Brotzu
Cagliari, Italy
Actively Recruiting
33
Firenze Ospedale Careggi
Careggi, Italy
Actively Recruiting
34
Azienda Ospedaliera di Catania
Catania, Italy
Actively Recruiting
35
Uni. di Modena
Modena, Italy
Not Yet Recruiting
36
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Actively Recruiting
37
Maurizano Torino (turin)
Turin, Italy
Actively Recruiting
38
Turin Uni. Hospital
Turin, Italy
Not Yet Recruiting
39
Vumc Amsterdam
Amsterdam, Netherlands
Actively Recruiting
40
Rijnstate Arnham
Arnhem, Netherlands
Actively Recruiting
41
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
42
UMC Gronigen
Groningen, Netherlands
Actively Recruiting
43
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430
Not Yet Recruiting
44
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
45
Diakonessenhuis
Utrecht, Netherlands
Actively Recruiting
46
Centro Hospital Uni Lisboa Norte
Lisbon, Portugal
Actively Recruiting
47
Hospital de Santa Marta
Lisbon, Portugal
Actively Recruiting
48
CHU Sao Joao
Porto, Portugal
Withdrawn
49
Hospital Universitari Germans
Badalona, Spain
Actively Recruiting
50
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Actively Recruiting
51
Hospital Universitari Valle Hebrón de Barcelona
Barcelona, Spain
Actively Recruiting
52
Hospital Universitario Central de Asturias, Oviedo
Oviedo, Spain
Actively Recruiting
53
Luzerner Kantonsspital
Lucerne, Switzerland
Actively Recruiting
54
Civico, Ospedale Regionale
Lugano, Switzerland
Withdrawn
55
Royal Derby Hospital
Derby, United Kingdom
Not Yet Recruiting
56
Hull Royal Infirmary
Hull, United Kingdom
Actively Recruiting
57
Manchester Royal Infirmary
Manchester, United Kingdom
Actively Recruiting
58
Oxford University Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
M
Michelle Durnan
S
Sammy Jassal
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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