Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Number of Patch Related Serious Adverse Events.
研究概览
简要总结
Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation.
The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.
详细描述
Xeltis has developed a medical device for treating pediatric cardiovascular patients requiring RVOT reconstruction. Xeltis' mission is to offer 'Solutions for a Lifetime' to cardiovascular patients. Xeltis has developed a unique technology based on novel biodegradable bio-materials allowing the regrowth of natural heart valves or blood vessels in patients' bodies from their own cells.
The principle of Xeltis' COR technology (COR stands for Cardiovascular Organ Regeneration) is to implant a biodegradable prosthesis of a blood vessels that is shaped like the part to be replaced. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. Tissue is regenerated and functional by the time the polymer is biodegraded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring a bidirectional cava-pulmonary anastomosis
- •Male or Female
- •Age: 2 months to 16 years
排除标准
- •Main Exclusion Criteria Arrhythmias as determined by ECG and/or at the investigator's discretion
- •Other clinically significant malformations
- •Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion
- •HIV-infection
- •Syphilis (Treponema pallidum)
- •Hepatitis-B and/or -C virus infection
- •Unwillingness of Parental/legal guardian to give consent
- •Treatment with other investigational products
- •Known or suspected noncompliance, drug or alcohol abuse of the parents/legal guardian
- •Inability of the parents/legal guardian 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 enrolment of the patient into the current study
- •Enrolment of the investigator's family members, employees and other dependent persons
研究组 & 干预措施
Xeltis Vascular Patch, Model COR-VP-001
Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.
干预措施: Xeltis Vascular Patch, Model COR-VP-001 (Device)
结局指标
主要结局
The Number of Patch Related Serious Adverse Events.
时间窗: 12 months
Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation
次要结局
- Number of Subjects With Loss of Functionality of the Patch.(12 months)
- Histological Evaluation(up to 12 Months after Implant)