European Aortic Data Collection Project

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (18)