EADC: European Aortic Data Collection Project

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05896397

Collaborator

(none)

600

Enrollment

Locations

90.1

Anticipated Duration (Months)

300

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Complex Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm Chronic Aortic Dissection	Procedure: Endovascular Aortic Treatments

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

European Aortic Data Collection Project

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.