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

Launched by VASCUTEK LTD. · Feb 23, 2012

Keywords

ClinConnect Summary

The Vascutek Hybrid device is designed for use during a frozen elephant trunk procedure. Each system is comprised of a fully sealed traditional prosthesis which is stented at the distal end. A minimum of 10 and a maximum of 30 patients with aneurysmal disease of the ascending aorta, the arch and the proximal descending aorta will receive a hybrid prosthesis implanted without the use of the delivery system and a minimum of 10 patients and a maximum of 20 patients will be implanted with a hybrid device using the delivery system.

The traditional prosthesis component is representative of curre...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
• • 2. Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
• • 3. Patient is able and willing to comply with the protocol and associated follow-up requirements
• Exclusion Criteria:
• • 1. Patients unfit for open surgical repair involving circulatory arrest
• • 2. Endocarditis or active infective disorder of the aorta
• • 3. Patients unwilling to give informed consent