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Trial record 1 of 5 for:    VASQ
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242343
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Laminate Medical Technologies

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE November 29, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • Primary Patency of AVF [ Time Frame: 6 months post AVF creation ]
    Proportion of patients with freedom from intervention since device placement
  • Occurrence of safety events [ Time Frame: Device implantation to 6 months post AVF creation ]
    The occurrence per patient access related safety events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03242343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VasQ External Support for Arteriovenous Fistula
Official Title  ICMJE A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arterio-Venous Fistula
  • ESRD
  • Steal Syndrome
  • Aneurysm
  • Renal Failure
  • Renal Disease
  • Diabetes Mellitus
  • Kidney Failure
Intervention  ICMJE Device: VasQ
An external support device for AV fistula
Study Arms  ICMJE 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.

Intervention: Device: VasQ
Publications * Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ™ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
144
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
129
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Binyamin Mittelman, M.Sc. +1-617-943-8234 Binyamin@laminatemedical.com
Contact: Daniella Bleistein, M.Sc. +972-3-6344246 ext 301 Daniella@laminatemedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242343
Other Study ID Numbers  ICMJE CD0121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laminate Medical Technologies
Study Sponsor  ICMJE Laminate Medical Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Noam Zilberman Laminate Medical Technologies Ltd.
PRS Account Laminate Medical Technologies
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP