Aneurysm of Aorta, Thoracic, Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Intramural Hematoma of the Thoracic Aorta, Penetrating Aortic Ulcers (PAUs), Ulcer-like Projection (ULP)
Conditions
Keywords
Castor™ Branched Aortic Stent Graft System, Cratos™ Branched Aortic Stent Graft System, TEVAR, thoracic aortic aneurysm (TAA), Penetrating Aortic Ulcer (PAU), Aortic Intramural Haematoma (IMH), Ulcer-like projection (ULP), thoracic aortic dissection
Brief 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.
Detailed description
The CEDAR registry is a post-market clinical study with retrospective and prospective enrollment and retrospective and prospective data collection.
Interventions
DEVICEImplantation 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.
DEVICEImplantation 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.
Sponsors
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate at 30 days, 6 months and at 1 - 5 years | 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 | 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 | at 30-days, 6 months and 1 year | 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. |
| 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 | — |
Countries
Germany, Switzerland
Contacts
CONTACTMaggie Shen, MD MSc
CONTACTAnne Woodman
STUDY_DIRECTORJing Wang
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Outcome results
None listed