An observational study in Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm and Aortic Arch Aneurysm, sponsored by Cook Research Incorporated. Recruiting at 18 sites in 6 countries. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Cook Research Incorporated (part of Cook Group Incorporated) · Observational
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patients who will be treated with a Cook CMD
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.
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.
Time frame: 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)
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
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Aortic Aneurysm, Thoracoabdominal →