Peripheral Vascular Disease Clinical Trial
— VJOfficial title:
Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass).
NCT number | NCT01514916 |
Other study ID # | KEK VD 64/08 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | January 12, 2012 |
Last updated | February 8, 2012 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Service de Chirurgie cardio-vasculaire CHUV | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Ab Medica Spa | Centre Hospitalier Universitaire Vaudois |
Switzerland,
Ferrari E, Tozzi P, von Segesser LK. The Vascular Join: a new sutureless anastomotic device to perform end-to-end anastomosis. Preliminary results in an animal model. Interact Cardiovasc Thorac Surg. 2007 Feb;6(1):5-8. Epub 2006 Nov 20. — View Citation
Tozzi P, Borghi E, Haesler E, Siniscalchi G, Motti A, Hayoz D, von Segesser LK. Progress in cardiovascular anastomoses: will the vascular join replace Carrel's technique? Eur J Cardiothorac Surg. 2006 Sep;30(3):425-30. Epub 2006 Jul 20. — View Citation
Tozzi P, Solem JO, Boumzebra D, Mucciolo A, Genton CY, Chaubert P, von Segesser LK. Is the GraftConnector a valid alternative to running suture in end-to-side coronary arteries anastomoses? Ann Thorac Surg. 2001 Sep;72(3):S999-1003. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of complications using Vascular Join | 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). | six month | Yes |
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