Evaluation of the Valiant Captivia Physician fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies (EVERGREEN)
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.
ID: NCT05479305
Sponsor
Sponsors
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 submissions
- Set-up activities (sites selection, insurance management, contract management)
- Project management
- Monitoring activities
- CoreLab activities
- Safety reporting
- CRF and Data management
- Clinical report
Countries
France
Number of investigational sites
1 site in France
Number of patients
40 patients expected
