European Aortic Data Collection Project

Cook Research Incorporated600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Complex Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm Chronic Aortic Dissection

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Hopital Marie Lannelongue

Le Plessis-Robinson, France

RECRUITING

CHU de Lille

Lille, France

RECRUITING

University Hospital Hamburg Eppendorf

Hamburg, Germany

RECRUITING

LMU Klinikum Munich

Munich, Germany

RECRUITING

St. Franzikus-Hospital Munster

Münster, Germany

RECRUITING

Klinnikum Nurnberg

Nuremberg, Germany

RECRUITING

PoliclinicoS Orsola Malpighi

Bologna, Italy

RECRUITING

Orsola Maplighi

Bologna, Italy

RECRUITING

...and 8 more locations

Outcomes

Primary Outcomes

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

European Aortic Data Collection Project

Overview

Conditions

Interventions

Eligibility

Locations (18)

Outcomes

Primary Outcomes

Central Contacts