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

NCT01514916 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-02-09

No results posted yet for this study

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.

Conditions

  • Peripheral Vascular Disease
  • Femoral Occlusive Disease
  • Femoropopliteal Occlusive Disease
  • Aortoiliac Atherosclerosis

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Ab Medica Spa

    lead INDUSTRY

Principal Investigators

  • Cosimo Puttilli, Eng. · Ab Medica Spa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514916 on ClinicalTrials.gov