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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: patients treated with Castor™ | Arch involving aortic pathologies treated with the Castor™ stent graft system. |
| |
| Cohort 2: patients treated with Cratos™ | Arch involving aortic pathologies treated with the Cratos™ stent graft system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with Castor™ stent graft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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™. | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 30 days, 6 months and at 1 - 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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approximately 100 patients in Europe, competitive enrolment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Shen, MD MSc | Contact | 00441235750800 | maggie.shen@endovastec-lm.com | |
| Anne Woodman | Contact | 00441235750800 | anne.woodman@endovastec-lm.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Wang | Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASKLEPIOS Kliniken St. Georg | Recruiting | Hamburg | 20099 | Germany |
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| Implantation with Cratos™ stent graft | Device | 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. |
|
| Rate of Endoleak | at 30 days, 6 months, and at 1 - 5 years |
| Branch occlusion rate | at 30 days, 6 months, and 1-5 year |
| Rate of perioperative retrograde type A aortic dissections | 30 days, 6 months, and at 1 - 5 years |
| Rate of reintervention | 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. | at 30-days, 6 months and 1 year |
| Incidence rate of spinal cord ischemia for the duration of the study | at 30 days, 6 months, and at 1 - 5 years |
| Stroke rate | at 30 days, 6 months, and at 1 - 5 years |
| All-cause mortality | at 30 days, 6 months, and at 1 - 5 years |
| Universitätsklinikum Münster (UKM) | Recruiting | Münster | 48149 | Germany |
|
| Hôpital de Sion | Recruiting | Sion | 1951 | Switzerland |
|
| Universitätsspital Zürich (USZ) | Recruiting | Zurich | CH-8091 | Switzerland |
|
| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| D001014 | Aortic Aneurysm |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D017545 | Aortic Aneurysm, Thoracic |
| D000094666 | Aortic Intramural Hematoma |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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