The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies. Clinical results will be used to apply for the CE certification.
This is a prospective, multicenter, non-randomized, single arm clinical study in patients presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on routine clinical assessments performed as part of the patients' standard care will be screened after obtaining the informed consent from the patients, and if eligible, enrolled and scheduled for the implantation procedure with the study device. Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events and device deficiencies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
thoracic endovascular repair (TEVAR) with a thoracic stent-graft
Freedom from aneurysm or dissection-related mortality
All deaths due to the treated pathology, including aneurysm rupture, complications of TEVAR leading to new aortic pathology (e.g., retrograde dissection leading to fatal cardiac tamponade).
Time frame: 30 days or less
Delivery and deployment success evaluation
Success will be based on the Delivery system evaluation, overall rate of vascular access complications * Rate of access failures * Rate of deployment system difficulties will be analyzed descriptively.
Time frame: 30 days or less
Major device-related adverse events (MAE)
MAEs include: * Endoleak (types I, Ill and IV) * Stent migration (\>10 mm)2 * Lumen occlusion * Aorta rupture * Conversion to open repair
Time frame: 30 days after the procedure
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