EUCTR2011-001187-21-DE进行中（未招募）不适用
A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow Tract. - SCRM-001 TEVG Study
niversity of Zurich0 个研究点开始时间: 2011年5月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Functional single ventricle physiology (functional single left ventricle,
- •functional single right ventricle, functional single biventricle)
- •- Male or female
- •- Age: 2 - 6 years
- •- Parental / legal guardian’s consent on behalf of the minor subject
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheter
- •- Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheter
- •- Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and / or angiography
- •- Moderate or severe outflow valve regurgitation requiring correction as
- •determined by echocardiography and / or angiography
- •- Outflow tract (aortic arch and isthmus) obstruction as excluded by
- •a) a residual outflow gradient of = 20mm Hg or
- •b) requirement of corrective surgery
- •as determined by angiography/cardiac catheter
- •- All arrhythmia other than normal sinus rhythm as determined by ECG
- •and / or at the investigator’s discretion
- •- Renal dysfunction as excluded by serum creatinin > ULN and / or urea
- •>ULN and / or at the investigator’s discretion
- •- Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT >
- •ULN and / or at the investigator’s discretion
- •- Coagulation disorders as defined by INR outside its normal value, PTT
- •>ULN and Fibrinogen - Transcutaneous O2 saturation < 65% or at the investigator’s discretion
- •- Immunodeficiency (ies) / Immune-syndromes
- •- Trisomia 21
- •- Asplenia as excluded by abdominal ultrasound
- •- Heterotaxia as excluded by abdominal ultrasound
- •- HIV-infection
- •- Syphillis (Treponema pallidum)
- •- Hepatitis-B and /or –C virus infection
- •- Unwillingness of Parental / legal guardian’s to give consent
- •- Contraindications on ethical grounds
- •- Treatment with other investigational products
- •- Known or suspected non-compliance, drug or alcohol abuse of the parents / legal guardian
- •- Inability of the parents / legal guardians to follow the procedures of the study, e.g. due to language problems
- •- Participation of the patient in another study within 30 days preceding
- •and during the present study
- •- Previous enrollment of the patient into the current study
- •- Enrollment of the investigator’s family members, employees and other
- •dependent persons
研究者
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