NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00172

Registered date:26/03/2014

Efficacy and safety of CP stent implantation for pulmonary stenosis associated with congenital heart diseases

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedPulmonary stenosis associated with congenital heart diseases
Date of first enrollment01/05/2014
Target sample size25
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DEVICE. Intervention1:Stent inplantation, Dose form:DEVICE, Route of administration:INTRACARDIAC.

Outcome(s)

Primary OutcomeEffective ratio of CP stent implantation. Timepoint:Angiography after CP stent implantation.
Secondary Outcome(1)% changes of the minimum lumen diameter following CP stent implantation. (2)Changes in hemodynamic parameters (3)Changes in NYHA classification. (4)Success ratio of CP stent implantation. (5)Restenosis which need re-intervention until 52 weeks after CP stent implantation.. Timepoint: Angiography after CP stent implantation, and in the follow-up period..

Key inclusion & exclusion criteria

Age minimumNo Limit
Age maximum<=40 YEARS
GenderBOTH
Include criteriaThose who have one or two lesions of post-operative pulmonary stenosis including those of post-fenestrated Fontan operation, and have a history of ineffective PTA for the lesion within one year of enrollment, or PTA for the lesion will not be effective. Candidates must meet following 1) or 2) criteria. 1)After Bi-ventricle repair; Either one of following (1)-(3) (1)Elevation of RVp associated with PS Systolic RVp/ Systolic ascending AOp > 0.7 (2)Systolic pressure gradient through the stenosis>20 mmHg (3)Stenosis ratio(1-MLD/ Ref vessel diameter)> 0.5 2)After Uni-ventricular repair; Either one of following(1)-(3) (1)Mean pressure gradient through the stenosis>3 mmHg (2)Stenosis ratio(1-MLD/ Ref vessel diameter)>0.5 (3)Morphologically definite stenosis complicated by SaO2<85%
Exclude criteria(1)Previously implanted stent in the target lesion (2)Contraindication for anti-coagulation or anti-platelet therapy (3)Hemorrhagic diathesis or Hyper-coagulation state (4)Active infection including endocarditis (5)Serious Liver and/or Kidney damage (6)Enrolled in the other clinical trials (7)Others

Related Information

Contact

public contact
Name Study Office
Address Division of Clinical Trials, Clinical Rearch Center,2-10-1 Ookura, Setagayaku, Tokyo
Telephone +81-3-5494-7120
E-mail
Affiliation National Center for Child Health and Development
scientific contact
Name Hideshi Tomita
Address Pediatric Heart Disease &amp; Adult Congenital Heart Disease Center,1-5-8 Hatanodai, Sinagawa-ku, Tokyo 142-8666, JAPAN
Telephone +81-3-3784-8000
E-mail
Affiliation Showa University Hospital