European Aortic Data Collection Project

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm; Chronic Aortic Dissection; Complex Abdominal Aortic Aneurysm; Aortic Arch Aneurysm

• Registration Number: NCT05896397
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (16)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

CHU de Lille; 🇫🇷 Lille, France

Hopital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

University Hospital Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

St. Franzikus-Hospital Munster; 🇩🇪 Münster, Germany

LMU Klinikum Munich; 🇩🇪 Munich, Germany

Klinnikum Nurnberg; 🇩🇪 Nürnberg, Germany

PoliclinicoS Orsola Malpighi; 🇮🇹 Bologna, Italy

Ospedal Policlinico San Martino-HSM; 🇮🇹 Genova, Italy

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy

Skane University Hospital Malmo; 🇸🇪 Malmö, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

St Thomas' Hospital; 🇬🇧 London, United Kingdom