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ACTIVE NOT RECRUITING
NCT03369977
NA

BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients

Sponsor: CryoLife, Inc.

View on ClinicalTrials.gov

Summary

A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.

Official title: Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2017-11-01

Completion Date

2020-11

Last Updated

2020-05-19

Healthy Volunteers

No

Interventions

DEVICE

BioGlue Surgical Adhesive

BioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix.

OTHER

Traditional Surgical Repair

Traditional surgical repair as determined by the surgeon

Locations (7)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, China

Nanjing First Hospital

Nanjing, China

Changhai Hospital,The Second Military Medical University

Shanghai, China

Zhongshan Hospital, Fudan University

Shanghai, China

Wuhan Asia Heart Hospital

Wuhan, China

Henan Provincial People's Hospital

Zhengzhou, China