JPRN-jRCT1080224691
Completed
未知
A Prospective, Multi-center, Single-arm Study with Congenital Heart Disease
ConditionsCongenital heart disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Congenital heart disease
- Sponsor
- TEIJIN LIMITED / TEIJIN PHARMA LIMITED
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •\- Patient with congenital heart disease requiring thoracotomy.
- •\- Patient who has at least 1 site in any of the septum, the outer wall and the vascular wall to be repaired.
- •\- Patient or the patient's legally acceptable representative who gives the written informed consent.
Exclusion Criteria
- •Exclusion Criteria:
- •\- Patient requiring emergency surgery.
- •\- Patient with non\-cardiac disease significantly raising surgical risk, significant non\-cardiac disease with life expectancy less than 6 months, or progressive non\-cardiac disease (liver failure, renal failure, cancer, etc.).
- •\- Patient who has coagulation test abnormality.
- •\- Patient who has familial arrhythmia.
- •\- Patient who has arrhythmia observed on preoperative ECG diagnosis.
- •\- Patient who is pregnant or lactating at the time of the consent.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Withdrawn
Phase 3
A Prospective, Multi-Center, Single Arm Study of the Conor Cobalt Chromium Reservoir Based Stent (Nevo) with Sirolimus Elution in Native Coronary Artery Lesions (CP-07 protocol)NL-OMON32462Conor Medsystems, LLC (maakt deel uit van Johnson & Johnson); contact persoon Emily Hergenreter40
Recruiting
Not Applicable
PASSAGE Clinical TrialJPRN-jRCT2032220496Kawahara Kazuo51
Not yet recruiting
Phase 4
The aim is to evaluate the safety and efficacy of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold in coronary artery disease patients.It enhances coronary luminal diameter in symptomatic ischemic heart disease, addressing de novo lesions in native coronary arteries.Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryCTRI/2024/02/062438Meril Diagnostics Private Limited
Recruiting
Not Applicable
SPECTACLE studyRectal cancerJPRN-jRCTs032230212Watanabe Jun400
Completed
Not Applicable
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteriesarterial stenosisstenotic coronary arteries10011082NL-OMON43455Shockwave Medical Inc.15