NCT01034007

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2008

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

8.1 years

First QC Date

January 29, 2008

Last Update Submit

February 28, 2018

Conditions

Single Ventricle Cardiac Anomaly

Keywords

tissue engineered vascular graft

Outcome Measures

Primary Outcomes (1)

  • graft failure requiring intervention

    3 years

Secondary Outcomes (1)

  • graft growth

    3 years

Study Arms (1)

Tissue Engineered Vascular Grafts

EXPERIMENTAL
Combination Product: Tissue Engineered Vascular Grafts

Interventions

Tissue Engineered Vascular GraftsCOMBINATION_PRODUCT

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

Tissue Engineered Vascular Grafts

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC).

You may not qualify if:

  • incomplete inferior vena cava (IVC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Blood Vessel Prosthesis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Christopher K Breuer, MD

    Nationwide Children's Hospital, Columbus, Ohio

    STUDY CHAIR

  • Toshiharu Shinoka, MD/PhD

    Nationwide Children's Hospital, Columbus, Ohio

    STUDY CHAIR

  • Mark Galantowicz, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Tissue Engineering

Study Record Dates

First Submitted

January 29, 2008

First Posted

December 17, 2009

Study Start

December 1, 2009

Primary Completion

December 26, 2017

Study Completion

January 23, 2018

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

US(1)