The Castor™ and Cratos™ Branched Aortic Stent Graft Systems are medical devices designed for the minimally invasive endovascular treatment of thoracic aortic pathologies in the descending aorta. The goal of this multi-centre retrospective and prospective observational registry study is to capture the short-, medium- to long-term safety and performance data of how Castor™ and Cratos™ stent-grafts work in real-world settings (everyday medical practice). The aim is to study approximately 100 patients in European hospitals, with competitive enrollment.
Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery
Age >18 years
Patients allergic to the materials of the device;
Patients with severe or potentially systemic infections that increase the chance of graft infection;
Minors and pregnant women;
Branch for other supra-aortic vessels than the LSA
approximately 100 patients in Europe, competitive enrolment
Cohort
Other
Implantation with Castor™ stent graft
DeviceTreatment of subjects diagnosed with thoracic aortic pathologies using the Castor™ Branched Aortic Stent-Graft and Delivery System. Follow up as per institutional standard of care.
Implantation with Cratos™ stent graft
DeviceTreatment of subjects diagnosed with thoracic aortic pathologies using the Cratos™ Branched Aortic Stent-Graft and Delivery System. Follow up as per institutional standard of care.
30-day all-cause mortality
A measure of the total number of patients participating in the CEDAR study who die from any cause within 30 days of the implantation of the branched aortic stent graft - Castor™ or Cratos™.
Technical success rate
Technical Success is defined as successful access and deployment of the endograft, including implantation of the branch into the target vessel, with patency of the branch and no evidence of type I or type III endoleak on completion angiography or cone-beam computed tomography. Additional intra-operative measures to achieve this, such as ballooning or branch extension with additional stent grafts, are also considered as primary technical success.
Clinical success rate at 30 days, 6 months and at 1 - 5 years
This is defined as Technical Success plus the absence of aortic related death, aortic rupture, graft infection, sac expansion \> 5mm, graft migration \>10mm, persistent endoleaks type I and III requiring re-intervention, conversion to open surgery, permanent paraplegia, disabling stroke or permanent dialysis.
Rate of Endoleak
Branch occlusion rate
Rate of perioperative retrograde type A aortic dissections
Click on the lead sponsor to view all of their trials.
