Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCeric Sàrl

About this trial

The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.

Clinical utility measures throughout the procedure and until discharge will be assessed

Eligibility criteria

Qualifiers

Subject is at least 18 years of age.

Subject understands and has signed an Informed Consent approved by the Sponsor for this study.

Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.

Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.

Disqualifiers

Subject has an aneurysmal, tortuous, or atherosclerotic LSA.

Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.

Subject has an aneurysmal, tortuous, or atherosclerotic BT.

Subject has an ascending aorta diameter > 40 mm

Trial design

Treatments tested in this trial

  • The Valiant Captivia Stent Graft

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ceric Sàrl

Lead sponsor

European Cardiovascular Research Center

Collaborator