New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease (VJ)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Peripheral Vascular Disease Femoral Occlusive Disease Femoropopliteal Occlusive Disease Aortoiliac Atherosclerosis |
Device: mechanical anastomosis without suture |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass). |
- Incidence of complications using Vascular Join [ Time Frame: six month ] [ Designated as safety issue: Yes ]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).
| Estimated Enrollment: | 30 |
-
Device: mechanical anastomosis without suture
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with peripheral vascular disease requiring vascular bypass (Fontaine stage 2B-3)
Exclusion Criteria:
- Pregnant women
- Patient requiring further surgery at the same time
- A patient with acute vascular occlusion.
- Hemodynamically unstable patient before surgery
Contacts and Locations| Contact: Piergiorgio Tozzi, Dr. PD&MER | +41213147367 | Piergiorgio.Tozzi@chuv.ch |
| Switzerland | |
| Service de Chirurgie cardio-vasculaire CHUV | Recruiting |
| Lausanne, Switzerland, CH-1011 | |
| Study Director: | Cosimo Puttilli, Eng. | Ab Medica Spa |
More Information
Publications:
| Responsible Party: | Ab Medica Spa |
| ClinicalTrials.gov Identifier: | NCT01514916 History of Changes |
| Other Study ID Numbers: | KEK VD 64/08 |
| Study First Received: | January 12, 2012 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Atherosclerosis Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease |
Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013