NCT01514916

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

First QC Date

January 12, 2012

Last Update Submit

February 8, 2012

Conditions

Peripheral Vascular DiseaseFemoral Occlusive DiseaseFemoropopliteal Occlusive DiseaseAortoiliac Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

mechanical anastomosis without sutureDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with peripheral vascular disease requiring vascular bypass (Fontaine stage 2B-3)

You may not qualify if:

  • Pregnant women
  • Patient requiring further surgery at the same time
  • A patient with acute vascular occlusion.
  • Hemodynamically unstable patient before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie cardio-vasculaire CHUV

Lausanne, CH-1011, Switzerland

RECRUITING

Related Publications (3)

  • 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. doi: 10.1016/j.ejcts.2006.05.029. Epub 2006 Jul 20.

    PMID: 16859919BACKGROUND

  • 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. doi: 10.1510/icvts.2006.137943. Epub 2006 Nov 20.

    PMID: 17669755BACKGROUND

  • 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. doi: 10.1016/s0003-4975(01)02953-8.

    PMID: 11565736BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Sutures

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Cosimo Puttilli, Eng.

    Ab Medica Spa

    STUDY DIRECTOR

Central Study Contacts

Piergiorgio Tozzi, Dr. PD&MER

CONTACT

+41213147367Piergiorgio.Tozzi@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 23, 2012

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

CH(1)