Dissection of Thoracic AortaDissection of Thoracic Descending AortaAneurysm of Aorta, ThoracicPenetrating Aortic Ulcers (PAUs)Intramural Hematoma of the Thoracic AortaUlcer-like Projection (ULP)
Investigational drug(s) / intervention(s)
Implantation with Castor™ stent graftImplantation with Cratos™ stent graft
Implantation with Castor™ stent graft: Treatment 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: Treatment 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery
* Age \>18 years
Exclusion Criteria:
* 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
* Rejection of participation.
Primary outcome measure(s)
30-day all-cause mortality — 30 days 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 — 24 hours 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.
Trial sites (4)
Facility
City
Region
Status
ASKLEPIOS Kliniken St. Georg
Hamburg
Germany
Recruiting
Universitätsklinikum Münster (UKM)
Münster
Germany
Recruiting
Hôpital de Sion
Sion
Switzerland
Recruiting
Universitätsspital Zürich (USZ)
Zurich
Switzerland
Recruiting
More Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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