New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease

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.

The 2 main objectives of this study are to assess if the device still works after 6 months (so called device's performance) and if it is as safe as standard technique (running or interrupted suture) in terms of incidence of complications as bleeding, infection and occlusion. Simple size has therefore been calculated in terms of equivalence risk. In this case the null hypothesis specify that the success rate Pc in the standard treatment is higher than the success rate PE in the vascular join treatment by at least some amount ß.

The alternative hypothesis specifies that PC - PE \< ß, which implies the 2 therapies are equivalent. The following formula provides the required number of patients for such a trial:

Ho: PC >(or =) PE + ß vs H1: PC \<(or =) PE + ß . Because, taking historical data as reference, the incidence of all complications in peripheral bypasses could be as high as 50% at 6 months, the number of 30 patients was selected.

The post-operative treatment and remote monitoring of patients remained unchanged (Aspirin 100 mg/d and control angiological at 3 and 6 months).

Patient's follow-up is the same as any other patient receiving femoral artery bypass, which means physical examination and Doppler ultrasound of the bypass before the discharge, 1, 3 and 6 months after the procedure.

If the patient misses the scheduled control, the PI will apply the procedure in use at the Cardiovascular Surgery Dpt to contact him, which includes phone calls to the patient, the contact person he/her identified at the admission and to the GP.