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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514916
Recruitment Status : Unknown
Verified February 2012 by Ab Medica Spa.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : February 9, 2012
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Ab Medica Spa

Brief Summary:

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 or disease Intervention/treatment Phase
Peripheral Vascular Disease Femoral Occlusive Disease Femoropopliteal Occlusive Disease Aortoiliac Atherosclerosis Device: mechanical anastomosis without suture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass).

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: mechanical anastomosis without suture
    The Vascular Join device is intended to be used to create sutureless end-to-end anastomosis between an artery and a venous or synthetic graft conduit. Any type of e-PTFE and Dacron conduits can be used.

Primary Outcome Measures :
  1. Incidence of complications using Vascular Join [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514916

Contact: Piergiorgio Tozzi, Dr. PD&MER +41213147367

Service de Chirurgie cardio-vasculaire CHUV Recruiting
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Ab Medica Spa
Centre Hospitalier Universitaire Vaudois
Study Director: Cosimo Puttilli, Eng. Ab Medica Spa