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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1092220172

Enrollment

Registered

2014-03-26

Start date

2014-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary stenosis associated with congenital heart diseases

Interventions

Intervention type:DEVICE Name of intervention:Stent inplantation Dose form / Japanese Medical Device Nomenclature:DEVICE CP stent Route of administration / Site of application:INTRACARDIAC Dose per ad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Those 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%

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Effective ratio of CP stent implantation	—

Secondary

Measure	Time frame
(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.	—

Countries

Japan

Contacts

Public ContactStudy Office

National Center for Child Health and Development

+81-3-5494-7120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026