European Aortic Data Collection Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular Aortic Treatments.
- Who it may be relevant to
- Registry conditions: Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, France, Germany, Italy, Sweden +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.
Interventions
- Procedure Endovascular Aortic Treatments
Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.
Primary outcome measures
- Rate of treatment success [Time frame: 12 months]
- Rate of safety outcomes [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
1\. Patients who will be treated with a Cook CMD
Exclusion criteria
- Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
- Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- University Hospital Hamburg Eppendorf — Hamburg
- LMU Klinikum Munich — Munich
- St. Franzikus-Hospital Munster — Münster
- Klinnikum Nurnberg — Nuremberg
Italy · 4 centers
- PoliclinicoS Orsola Malpighi — Bologna
- Orsola Maplighi — Bologna
- Ospedal Policlinico San Martino-HSM — Genova
- IRCCS San Raffaele Hospital — Milan
United Kingdom · 4 centers
- University Hospitals Birmingham NHS Foundation Trust — Birmingham
- North Bristol NHS Trust — Bristol
- St Thomas' Hospital — London
- St Barthowlomew's — London
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Rigshospitalet — Copenhagen
France · 2 centers
- Hopital Marie Lannelongue — Le Plessis-Robinson
- CHU de Lille — Lille
Sweden · 2 centers
- Skane University Hospital Malmo — Malmö
- Uppsala University Hospital — Uppsala
Identifiers
NCT: NCT05896397 · MDR-2091