RecruitingNot ApplicableNCT05479305

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


Sponsor

Ceric Sàrl

Enrollment

30 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the Valiant Captivia Physician Fenestrated Stent Graft System — a custom-designed device for treating complex aortic arch problems including aneurysms, penetrating ulcers, and Type B aortic dissections — in patients who need urgent repair and cannot wait for a custom-made device. You may be eligible if: - You are 18 or older - You have a thoracic aortic aneurysm, penetrating aortic ulcer, or Type B aortic dissection requiring treatment - Your aortic anatomy meets specific sizing and structural requirements for the device - You are at high surgical risk and need semi-urgent repair - You are affiliated with the social security system You may NOT be eligible if: - Your arteries supplying the arms and brain are diseased, tortuous, or aneurysmal - You have severe aortic calcification, thrombus at sealing sites, or an ascending aorta larger than 40 mm - You have connective tissue disease (e.g., Marfan syndrome), active infection, mycotic aneurysm, or acute renal failure - You had a stroke or heart attack within the past 3 months - You have bleeding disorders, are pregnant, or have a life expectancy under 2 years - You are currently in another device or drug clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe Valiant Captivia Stent Graft

Aortic arch/Descending aorta Repair


Locations(4)

CH de Brest

Brest, France

Hôpital Louis Pradel

Bron, France

CHU de Montpellier

Montpellier, France

CH d'Orléans

Orléans, France

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NCT05479305


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