Complex Abdominal Aortic AneurysmEADCNCT05896397
European Aortic Data Collection Project
An observational study of Complex Abdominal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, run by Cook Research Incorporated at 18 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm
- What is being tested?
- Endovascular Aortic Treatments
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 31 May 2023to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.
Who may be able to join
- 1. Patients who will be treated with a Cook CMD
Who cannot join
- 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.
Trial locations and contacts
18 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 6 countries
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Hamburg Eppendorf
Hamburg, Germany, 20251
- Recruiting
LMU Klinikum Munich
Munich, Germany, 80337
- Recruiting
St. Franzikus-Hospital Munster
Münster, Germany, 48145
- Recruiting
Klinnikum Nurnberg
Nuremberg, Germany, 90471
Italy4 sites, 4 recruiting
- Recruiting
PoliclinicoS Orsola Malpighi
Bologna, 40138
- Recruiting
Orsola Maplighi
Bologna
- Recruiting
Ospedal Policlinico San Martino-HSM
Genova, 16132
- Recruiting
IRCCS San Raffaele Hospital
Milan, 20132
United Kingdom4 sites, 4 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B9 5SS
- Recruiting
North Bristol NHS Trust
Bristol, BS10 5NB
- Recruiting
St Thomas' Hospital
London, SE1 9RT
- Recruiting
St Barthowlomew's
London
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Denmark, 8200
- Recruiting
Rigshospitalet
Copenhagen, Denmark, 2100
France2 sites, 2 recruiting
- Recruiting
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
- Recruiting
CHU de Lille
Lille, 59037
Sweden2 sites, 2 recruiting
- Recruiting
Skane University Hospital Malmo
Malmö, SE-205-02
- Recruiting
Uppsala University Hospital
Uppsala, 75309
About this study
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.
- Conditions
- Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
- Being tested
- Endovascular Aortic Treatments
- Keywords
- Complex aortic repair, Aortic aneurysm, Aortic dissection, Fenestrated/branched endograft, Custom-made endovascular graft
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aneurysm, Aortic Arch, Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic TreatmentsProcedure or surgery
Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment success
Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components.
Measured: 12 months
Rate of safety outcomes
Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start31 May 2023
- Primary completionJan 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Haulon, MD,PhD, Principal investigator, Hopital Marie Lannelongue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896397
- Sponsor's protocol ID
- MDR-2091
- Acronym
- EADC
- Status last verified
- Jun 2026
- First submitted
- 31 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Aortic Data Collection Project
- ClinicalTrials.gov ID
- NCT05896397
- Acronym / sponsor ID
- EADC / MDR-2091
- Conditions
- Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
- Keywords
- Complex aortic repair, Aortic aneurysm, Aortic dissection, Fenestrated/branched endograft, Custom-made endovascular graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.
Key inclusion criteria (1 listed)
- 1. Patients who will be treated with a Cook CMD
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Aortic TreatmentsUse of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections. | Procedure or surgery | – |
Primary outcome
Rate of treatment success
Time frame: 12 months
Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components.
Rate of safety outcomes
Time frame: 30 days
Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Complex Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Thoracoabdominal Aortic Aneurysm, Endovascular Repair
RecruitingObservational study
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
Complex Abdominal Aortic Aneurysms
Recruiting
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Enrolling by invitationObservational study
Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
Aortic Aneurysm, Aortic Aneurysm Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Haulon, MD,PhD principal investigator
Hopital Marie Lannelongue
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Abdominal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, run by Cook Research Incorporated at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Italy, United Kingdom, Denmark, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregoire Masliah (+41 795 490 954, gregoire.masliah@cookmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment success (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.