Peripheral Vascular Disease Clinical Trial
Official title:
Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass).
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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