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VasQ External Support for Arteriovenous Fistula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242343
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : February 19, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: N/A
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 : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: VasQ device implantation

Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints.

Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.

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



Information from the National Library of Medicine

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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:

  1. Main study cohort: 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.

    Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.

  2. Male and female participants.
  3. Age 18-80 years.
  4. Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria:

  1. Patients with the planned index procedure being a revision surgery of an existing fistula.
  2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.

    Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.

  3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.

    Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.

  4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
  5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
  6. Patients with central venous stenosis or obstruction on the side of surgery.
  7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
  8. Known coagulation disorder.
  9. Congestive heart failure NYHA class ≥ 3.
  10. Prior steal on the side of surgery.
  11. Known allergy to nitinol.
  12. Life expectancy less than 30 months.
  13. Patients expecting to undergo kidney transplant within 6 months of enrollment.
  14. Women of child bearing age without documented current negative pregnancy test.
  15. Inability to give consent and/or comply with the study follow up schedule.

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


Locations
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United States, Alabama
Grandview Medical Center
Birmingham, Alabama, United States, 35243
United States, Arizona
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, United States, 85012
United States, Illinois
Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Lutheran Medical Group/Indiana Ohio Heart
Fort Wayne, Indiana, United States, 46804
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Montefiore Medical Center
New York, New York, United States, 10467
United States, North Carolina
Charlotte PA
Charlotte, North Carolina, United States, 28207
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University Wexner Meidcal Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29615
United States, Texas
Cardiothoracic and Vascular Surgeons, P.A.
Austin, Texas, United States, 78756
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Laminate Medical Technologies
Investigators
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Study Director: Noam Zilberman Laminate Medical Technologies Ltd.

Additional Information:
Publications:
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Responsible Party: Laminate Medical Technologies
ClinicalTrials.gov Identifier: NCT03242343    
Other Study ID Numbers: CD0121
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Renal Insufficiency
Aneurysm
Arteriovenous Fistula
Fistula
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Vascular Fistula
Congenital Abnormalities