Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of complications using Vascular Join
研究概览
简要总结
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results. It allows a perfect mechanical anastomosis without suture, avoiding the disadvantages of operation length and difficulty of the act, thrombosis, clamping and embolism. The "Vascular Join" creates automatically the connection between the vein or prosthesis at both ends and bridging the artery while preventing the passage of the needle and suture through the vessel wall and clamping pressure. This makes it very easy to construct a vascular anastomosis using the endoscopic technique less traumatic for the patient, lessen the pain of the patient, thereby reducing health care costs by reducing the length of hospital stay.
No part of the device is in contact with the patient's blood because the whole system remains in the thickness of the arterial wall and outside the vessel. Thus, the formation of intimal hyperplasia is greatly diminished and the risk of occlusion of the anastomosis is less than the currently available risk when a suture is used. This risk is shown by studies on animals in labs, with a mean follow up of 12 months. The Vascular Join creates a perfect congruence of anastomosed vessels because it allows a perfect match between each vascular tunic.
The medical device Vascular Join has been designed in order to:
- Reduce the suture time;
- Reduce the risk of occlusion of vein after the surgical process;
- Avoid the contact risk between the external material steel (surgical needle) and blood;
- Standardize the quality of anastomoses independently of the skill of the surgeon.
详细描述
The Vascular Join consists of two symmetrical parts, called Vessel Rings, each of which is fixed to the extremity of the two conduits being joined together. A third ring, called Coupler Ring, keeps the two rings together with a snap-on system and guarantees the continuity of the severed conduit in an end-to-end configuration. Each ring is made within a cylinder-type steel AISI 316L. The circular shape of the Vessel rings, the inner part in particular, provides a natural physiologic vascular reconstruction reducing the risk of thrombosis and myointimal hyperplasia at the anastomotic site.
We propose to evaluate the ease of use, efficiency, security of the "Vascular Join" and long-term results (6 months) in patients with peripheral vascular disease requiring vascular bypass. Each patient has a proximal anastomosis and distal anastomosis performed with the "Vascular Join". Next, measure the flow in the bypass through an ultrasonic flow meter.
The objective is to achieve a vascular bypass using the mechanical device described above and to define the incidence of major and minor vascular complications in the postoperative 7 days (or until discharge), as well as primary and secondary permeability bypass after 6 months. What we define as major vascular complications are death, stroke, acute occlusion, partial occlusion, and reoperation for redo the mechanical anastomosis. We define as minor complications residual pain, and bleeding.
In the case of partial or complete failure of the mechanical suture, the surgeon can add points of suture or performing anastomosis with the traditional technique.
After 6 months, a Doppler will allow us to compare to each patient, the morphology of the anastomoses performed with the "Vascular Join," and the permeability of the bypass. The results will be compared to historical results of primary and secondary permeability present in the literature.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with peripheral vascular disease requiring vascular bypass (Fontaine stage 2B-3)
排除标准
- •Pregnant women
- •Patient requiring further surgery at the same time
- •A patient with acute vascular occlusion.
- •Hemodynamically unstable patient before surgery
结局指标
主要结局
Incidence of complications using Vascular Join
时间窗: six month
The objective is to achieve a vascular bypass using the mechanical device Vascular Join and define the incidence of vascular complications (bleeding, infection and occlusion) in the postoperative 7 days (or until discharge), as well as primary and secondary permeability bypass after 6 months. The incidence is compared with the Vascular standard technique (running or interrupted suture).
次要结局
未报告次要终点