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VasQ External Support for Arteriovenous Fistula

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ClinicalTrials.gov Identifier: NCT03242343
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Laminate Medical Technologies

Brief Summary:

This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow.

All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.


Condition or disease Intervention/treatment Phase
Arterio-Venous Fistula ESRD Steal Syndrome Aneurysm Renal Failure Renal Disease Diabetes Mellitus Kidney Failure Device: VasQ Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: VasQ device implantation Device: VasQ
An external support device for AV fistula




Primary Outcome Measures :
  1. Primary Patency of AVF [ Time Frame: 6 months post AVF creation ]
    Proportion of patients with freedom from intervention since device placement

  2. Occurrence of safety events [ Time Frame: Device implantation to 6 months post AVF creation ]
    The occurrence per patient access related safety events



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
  • Male and female participants.
  • Age 18-80 years.
  • Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria:

  • Patients with the planned index procedure being a revision surgery of an existing fistula.
  • Target arteries smaller than 3 mm in diameter.
  • Target vein smaller than 3 mm or larger than 6 mm in diameter.
  • Significantly stenotic target vein on the side of surgery.
  • Patients with central venous stenosis or obstruction on the side of surgery.
  • Depth of vein greater than 8 mm on side of surgery.
  • Known coagulation disorder.
  • Prior steal on the side of surgery.
  • Known allergy to nitinol.
  • Life expectancy less than 30 months.
  • Patients expecting to undergo kidney transplant within 6 months of enrollment.
  • Women of child bearing age without documented current negative pregnancy test.

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 ClinicalTrials.gov identifier (NCT number): NCT03242343


Contacts
Contact: Binyamin Mittelman, M.Sc. +1-617-943-8234 Binyamin@laminatemedical.com
Contact: Maya Vizel, M.Sc. +972-3-6344246 ext 312 Maya@laminatemedical.com

Locations
United States, Arizona
Arizona Kidney Disease & Hypertension Center Recruiting
Phoenix, Arizona, United States, 85012
Contact: Shouwen Wang, Dr.         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Samir Shah, Dr.         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Alik Farber, Dr.         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Yael Vin, Dr.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kenneth Woodside, Dr.         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Paul B. Kreienberg, Dr.         
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Stuart Greenstein, Dr.         
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Larry Scher, Dr.         
United States, North Carolina
Charlotte PA Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Jason Burgess, Dr.         
United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: Levester Kirksey, Dr.         
Ohio State University Wexner Meidcal Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ronald P. Pelletier         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29615
Contact: Joe Blas, Dr.         
United States, Texas
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Eric Peden, Dr.         
Sponsors and Collaborators
Laminate Medical Technologies
Investigators
Study Director: Noam Zilberman Laminate Medical Technologies Ltd.

Additional Information:
Publications:
Responsible Party: Laminate Medical Technologies
ClinicalTrials.gov Identifier: NCT03242343     History of Changes
Other Study ID Numbers: CD0121
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Aneurysm
Renal Insufficiency
Fistula
Arteriovenous Fistula
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Vascular Fistula
Congenital Abnormalities