European Aortic Data Collection Project

NCT05896397 — Recruiting, 600 participants, Cook Research Incorporated

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RegistryNCT05896397, acronym EADC
StatusRecruiting
Study typeObservational
Enrollment600 (Estimated)
SponsorCook Research Incorporated (Industry)
ConditionsComplex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
InterventionsEndovascular Aortic Treatments (Procedure)
Datesstart 2023-05-31, primary completion 2027-01-01 (estimated), completion 2030-12-01 (estimated), first posted 2023-06-09, last updated 2026-06-04
Locations18 sites in Denmark, France, Germany, Italy, Sweden, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Complex Abdominal Aortic Aneurysm All trials for Thoracoabdominal Aortic Aneurysm All trials of Endovascular Aortic Treatments

-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.

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.

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+Arms and interventions

  • Endovascular Aortic Treatments (Procedure): Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.

+Outcome measures

Primary outcomes

  • Rate of treatment success [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 [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)

+Eligibility

Sex: All

Inclusion Criteria:

1\. Patients who will be treated with a Cook CMD

Exclusion Criteria:

1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
2. 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.

+Locations (18)

FacilityCityCountryStatus
Aarhus University HospitalAarhus, DenmarkDenmarkRecruiting
RigshospitaletCopenhagen, DenmarkDenmarkRecruiting
Hopital Marie LannelongueLe Plessis-RobinsonFranceRecruiting
CHU de LilleLilleFranceRecruiting
University Hospital Hamburg EppendorfHamburg, GermanyGermanyRecruiting
LMU Klinikum MunichMunich, GermanyGermanyRecruiting
St. Franzikus-Hospital MunsterMünster, GermanyGermanyRecruiting
Klinnikum NurnbergNuremberg, GermanyGermanyRecruiting
PoliclinicoS Orsola MalpighiBolognaItalyRecruiting
Orsola MaplighiBolognaItalyRecruiting
Ospedal Policlinico San Martino-HSMGenovaItalyRecruiting
IRCCS San Raffaele HospitalMilanItalyRecruiting
Skane University Hospital MalmoMalmöSwedenRecruiting
Uppsala University HospitalUppsalaSwedenRecruiting
University Hospitals Birmingham NHS Foundation TrustBirminghamUnited KingdomRecruiting
North Bristol NHS TrustBristolUnited KingdomRecruiting
St Thomas' HospitalLondonUnited KingdomRecruiting
St Barthowlomew'sLondonUnited KingdomRecruiting

+Investigators