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RECRUITING
NCT04467671
PHASE2

Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

Sponsor: Nationwide Children's Hospital

View on ClinicalTrials.gov

Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Official title: Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2020-07-15

Completion Date

2027-08

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Tissue Engineered Vascular Grafts

Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States