UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061574 |
|---|---|
| Receipt number | R000070449 |
| Scientific Title | Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study) |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/14 17:29:21 |
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Basic information
Public title
Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)
Acronym
J-CONTEGRA Study
Scientific Title
Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)
Scientific Title:Acronym
Japan Multi-institutional Registry Study on Long-term Outcomes of Contegra Conduit in Pediatric Congenital Heart Disease (J-CONTEGRA Study)
Region
| Japan |
Condition
Condition
Patients who underwent right ventricular outflow tract reconstruction using Contegra artificial blood vessels during surgery for congenital heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the long-term outcomes and prognostic factors associated with the use of Contegra artificial blood vessels in Japan.
This will aid in appropriate patient selection and the choice of surgical materials, thereby contributing to improved survival and quality of life for children with congenital heart disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint
1. Conduit durability (rate of avoidance of reintervention, rate of avoidance of insufficiency and stenosis)
Continuous variables are presented as the median (interquartile range), and categorical variables as counts (proportions). Survival analysis will be performed using the Kaplan-Meier method, and comparisons between groups will be conducted using the log-rank test. Multivariate analysis will employ the Cox proportional hazards model to identify risk factors. Changes in ductal function over time will be analyzed using a mixed-effects model. Statistical significance is set at P < 0.05.
Key secondary outcomes
Secondary endpoints
1. Optimal patient size for 16-mm and 14-mm artificial vessels
2. Changes in annulus diameter over time (degree of expansion over time)
3. Incidence of infective endocarditis in the long term
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated at facilities affiliated with the Japanese Society for Pediatric Cardiac Surgery that have performed 10 or more Contegra artificial vascular graft procedures between April 1, 2013, and December 31, 2024
No age restrictions
Key exclusion criteria
Cases for which no postoperative follow-up was conducted
Cases in which the medical records are significantly incomplete and cannot be evaluated
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hirano |
Organization
Saitama Medical University International Medical Center
Division name
Pediatric Cardiovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City, Saitama, Japan
TEL
070-1799-3778
hirano.akinori@gmail.com
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hirano |
Organization
Saitama Medical University International Medical Center
Division name
Pediatric Cardiovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City, Saitama, Japan
TEL
070-1799-3778
Homepage URL
hirano.akinori@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Medtronic inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center, Clinical Research Properness Promotion Center
Address
1397-1 Yamane, Hidaka City, Saitama, Japan
Tel
042-984-4523
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
262
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Variables and data management]
Demographic, anatomical, operative, perioperative and longitudinal follow-up variables were abstracted from the medical record into a standardised electronic case-report form. Variables included patient demographics; primary diagnosis; conduit characteristics (size, ring support, external covering, bicuspidisation); operative procedure; cardiopulmonary bypass and aortic cross-clamp times; antithrombotic therapy; serial transthoracic echocardiographic grading of pulmonary regurgitation (none / mild / moderate / severe) and peak transconduit flow velocity at discharge and at annual intervals; postoperative cardiac catheterisation data including pulmonary vascular resistance; and all conduit-related events. Data were anonymised at source with site-specific identifiers, transferred to the coordinating centre and verified centrally before locking the dataset.
[Endpoints and definitions]
The primary endpoint was freedom from pathological conduit explantation, defined as surgical removal of the Contegra conduit for any cause other than patient-prosthesis mismatch (PPM). PPM was defined a priori as conduit explantation indicated by the operating surgeon on the basis of somatic outgrowth in the absence of any structural conduit failure (i.e., absence of stenosis, regurgitation, infective endocarditis, aneurysmal dilatation or compression of adjacent structures).
Secondary endpoints were: overall survival; freedom from all-cause conduit explantation; freedom from conduit-related infective endocarditis (IE); freedom from catheter intervention on the conduit or proximal branch pulmonary arteries; freedom from compression of adjacent structures; and serial changes in transthoracic echocardiographic measures of conduit function.
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070449
