CompletedPhase 1/2

Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure

Germany34 participantsStarted 2010-05

Plain-language summary

The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.

Who can participate

Age range29 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
✓. Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
✓. Patient is able and willing to comply with the protocol and associated follow-up requirements

Exclusion criteria

✕. Patients unfit for open surgical repair involving circulatory arrest
✕. Endocarditis or active infective disorder of the aorta
✕. Patients unwilling to give informed consent

What they're measuring

Primary Safety Endpoint

Timeframe: ≤30 days

Primary Effectiveness Endpoint

Timeframe: ≤365 days

Trial details

NCT IDNCT01541410

SponsorVascutek Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta trials