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B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair — B-SAFER  

Aortic Dissection Clinical Trial

Official title:
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Clinical Trial Summary

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.

Clinical Trial Description

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04747626
Study type Interventional
Source The Cleveland Clinic
Contact Eric Roselli, M. D.
Phone 216-444-0995
Email roselle@ccf.rg
Status Recruiting
Phase N/A
Start date March 25, 2021
Completion date December 31, 2027
View Details
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