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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Ab Medica Spa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Ab Medica Spa
ClinicalTrials.gov Identifier:
NCT01514916
First received: January 12, 2012
Last updated: February 8, 2012
Last verified: February 2012
  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).

Resource links provided by NLM:


Further study details as provided by Ab Medica Spa:

Primary Outcome Measures:
  • 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
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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514916

Contacts
Contact: Piergiorgio Tozzi, Dr. PD&MER +41213147367 Piergiorgio.Tozzi@chuv.ch

Locations
Switzerland
Service de Chirurgie cardio-vasculaire CHUV Recruiting
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Ab Medica Spa
Centre Hospitalier Universitaire Vaudois
Investigators
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
Arteriosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014