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.
The CEDAR registry is a post-market clinical study with retrospective and prospective enrollment and retrospective and prospective data collection.
Study Type
OBSERVATIONAL
Enrollment
100
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.
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.
ASKLEPIOS Kliniken St. Georg
Hamburg, Germany
RECRUITINGUniversitätsklinikum Münster (UKM)
Münster, Germany
RECRUITINGHôpital de Sion
Sion, Switzerland
RECRUITINGUniversitätsspital Zürich (USZ)
Zurich, Switzerland
RECRUITING30-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™.
Time frame: 30 days
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.
Time frame: 24 hours
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.
Time frame: at 30 days, 6 months and at 1 - 5 years
Rate of Endoleak
Time frame: at 30 days, 6 months, and at 1 - 5 years
Branch occlusion rate
Time frame: at 30 days, 6 months, and 1-5 year
Rate of perioperative retrograde type A aortic dissections
Time frame: 30 days, 6 months, and at 1 - 5 years
Rate of reintervention
Time frame: at 30 days, 6 months, and at 1-5 years
Combined endpoint major adverse events
all-cause mortality, myocardial infarction, respiratory failure with postoperative prolonged mechanical ventilation \> 24h, renal function declining in a GFR \> 50% reduction to perioperative, bowel ischemia requiring surgical resection, major stroke and permanent paraplegia.
Time frame: at 30-days, 6 months and 1 year
Incidence rate of spinal cord ischemia for the duration of the study
Time frame: at 30 days, 6 months, and at 1 - 5 years
Stroke rate
Time frame: at 30 days, 6 months, and at 1 - 5 years
All-cause mortality
Time frame: at 30 days, 6 months, and at 1 - 5 years
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