Valiant Captivia physician fEnestRated stent GRaft system in the aortic arch and dEscendiNg thoracic aorta pathologies

Sponsor Name

Ceric

Brief summary

EVERGREEN study is a prospective, multi-center, multinational, single arm study. The objective is to  evaluate the safety and effectiveness of Valiant Captivia physician fenestrated Stent Graft System in the Aortic Arch and descending aorta pathologies. 30 patients will be enrolled in 9 sites in France (6) and Italy (3). Patients will be followed up to 3 years after procedure.

Primary endpoints

• Safety endpoint: at 30 days post procedure composite of aorta-related mortality, stroke/TIA, paraplegia/paraparesis, left arm/hand ischemia
• Effectiveness endpoints: stent delivery, vessels unintentional coverage, delivery system removal, aortic lesions exclusion

CERC Services

Clinical trial documentation,

Regulatory Submission,

Set-up activities (sites selection, insurance management, contract management),

Project Management,

Monitoring,

CoreLab activities,

Safety reporting,

Data Management,

Clinical report

Countries

2 countries in Europe: France and Italy

Number of patients: 30

Number of investigational sites: 9