Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.
详细描述
The Vascutek Hybrid device is designed for use during a frozen elephant trunk procedure. Each system is comprised of a fully sealed traditional prosthesis which is stented at the distal end. A minimum of 10 and a maximum of 30 patients with aneurysmal disease of the ascending aorta, the arch and the proximal descending aorta will receive a hybrid prosthesis implanted without the use of the delivery system and a minimum of 10 patients and a maximum of 20 patients will be implanted with a hybrid device using the delivery system.
The traditional prosthesis component is representative of current Gelweave™ product. It is a woven polyester graft, crimped to maintain the lumen and gel coated to ensure that it will seal immediately. The stented section of the graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and Nitinol ring stents, which are attached to fabric with braided polyester sutures.
The delivery system is a central catheter comprised of a stainless steel braided, Isoplast-Pebax co-extrusion which has been locally strengthened to provide adequate guidewire lumen and sufficient stiffness to deploy the device. The outer sheath is 24Fr extruded PTFE with a groove to provide a localised splitting during deployment. The handle components are moulded in K-Resin & thermoplastic polyurethane to fulfil the functional requirements of the product.
The compacted endoprosthesis is placed through the opened aortic arch and deployed leaving the stented section positioned inside the descending aorta. The device is then released from the delivery system and the handle components removed leaving the full graft in situ and correctly positioned. This allows the surgeon to complete the aortic arch repair as required.
The materials of the endoprosthesis section, and of the traditional prosthesis section of the Hybrid Device are identical to those of current Vascutek product (Anaconda™ Stent Graft System - endoprosthesis; and Gelweave™ - standard vascular graft). All materials used in the delivery system are well established in medical applications.
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
- 29 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
- •Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
- •Patient is able and willing to comply with the protocol and associated follow-up requirements
排除标准
- •Patients unfit for open surgical repair involving circulatory arrest
- •Endocarditis or active infective disorder of the aorta
- •Patients unwilling to give informed consent
结局指标
主要结局
Primary Safety Endpoint
时间窗: ≤30 days
The primary safety endpoint will be the proportion of subjects free from paraplegia, secondary conversion to conventional open surgical repair and death due to device or procedure related complications ≤30 days post-procedure.
Primary Effectiveness Endpoint
时间窗: ≤365 days
The primary effectiveness endpoint will be successful aneurysm treatment, defined as a composite endpoint of subjects who have successful delivery and deployment of the Vascutek Hybrid Device at the initial procedure and at ≤365 days post-procedure.
次要结局
- Technical Success(Pre-discharge, 6 and 12 months)
- Assessment of Stent Graft Migration and Integrity(Pre-discharge, 6 and 12 months)