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A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

NCT01034007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-03-02

No results posted yet for this study

Summary

An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.

Conditions

  • Single Ventricle Cardiac Anomaly

Interventions

COMBINATION_PRODUCT

Tissue Engineered Vascular Grafts

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

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Gunze Limited

    collaborator OTHER

  • Christopher Breuer

    lead OTHER

Principal Investigators

  • Christopher K Breuer, MD · Nationwide Children's Hospital, Columbus, Ohio

  • Toshiharu Shinoka, MD/PhD · Nationwide Children's Hospital, Columbus, Ohio

  • Mark Galantowicz, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2017-12-26
Completion
2018-01-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034007 on ClinicalTrials.gov