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

Phase 3

Completed

• Conditions: Pulmonary stenosis associated with congenital heart diseases

• Registration Number: JPRN-jRCT1092220172
• Lead Sponsor: Hideshi Tomita

Brief Summary

Efficacy and safety of CP stent implantation using BIB and Z-MED II balloon was demonstrated by our clinical trial for pulmonary stenosis associated with congenital heart diseases.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-26
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective ratio of CP stent implantation

Secondary Outcome Measures

Name	Time	Method
(1)% changes of the minimum lumen diameter following CP stent implantation.<br>(2)Changes in hemodynamic parameters<br>(3)Changes in NYHA classification.<br>(4)Success ratio of CP stent implantation.<br>(5)Restenosis which need re-intervention until 52 weeks after CP stent implantation.