European Aortic Data Collection Project

Thoracoabdominal Aortic Aneurysm Clinical Trial

— EADC  

Official title:

European Aortic Data Collection Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896397
• Other study ID #: MDR-2091
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: December 2030

Study information

• Verified date: June 2024
• Source: Cook Group Incorporated
• Contact: Jane Nygaard.Erikson
• Phone: +45 56868678
• Email: janenygaard.eriksen[@]CookMedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2030
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracoabdominal
• Aortic Arch Aneurysm
• Aortic Dissection
• Complex Abdominal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
France	Hopital Marie Lannelongue	Le Plessis-Robinson
France	CHU de Lille	Lille
Germany	University Hospital Hamburg Eppendorf	Hamburg
Germany	LMU Klinikum Munich	Munich
Germany	St. Franzikus-Hospital Munster	Münster
Germany	Klinnikum Nurnberg	Nürnberg
Italy	PoliclinicoS Orsola Malpighi	Bologna
Italy	Ospedal Policlinico San Martino-HSM	Genova
Italy	IRCCS San Raffaele Hospital	Milan
Sweden	Skane University Hospital Malmo	Malmö
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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)	30 days