European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™

ConditionsDissection of Thoracic Aorta Dissection of Thoracic Descending Aorta Aneurysm of Aorta, Thoracic Penetrating Aortic Ulcers (PAUs)Intramural Hematoma of the Thoracic Aorta Ulcer-like Projection (ULP)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShanghai MicroPort Endovascular MedTech（Group）Co., Ltd

About this trial

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 criteria

Qualifiers

Implantation of a Castor™ or Cratos™ single branch endoprothesis with incorporation of the left subclavian artery

Age >18 years

Disqualifiers

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

Trial design

Treatments tested in this trial

Implantation with Castor™ stent graft
Implantation with Cratos™ stent graft

Treatment groups

100 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Lead sponsor

Source ClinicalTrials.gov