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VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ (VALUE)

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ClinicalTrials.gov Identifier: NCT03246984
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Laminate Medical Technologies

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE September 7, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Primary patency of AV fistula [ Time Frame: 6 months post AVF creation ]
Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03246984 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 VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
Official Title  ICMJE A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
Brief Summary This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 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
  • Kidney Failure, Chronic
  • Kidney Diseases
  • Renal Failure Chronic
  • ESRD
  • Arteriovenous Fistula Thrombosis
Intervention  ICMJE Device: VasQ
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Study Arms  ICMJE Experimental: VasQ device implantation
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: October 4, 2018)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
50
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
  2. Age 18-80 years
  3. Male and female participants
  4. Patients willing and able to attend follow up visits over a period of 12 months

Exclusion Criteria:

  1. Patients with the planned index procedure being a revision surgery of an existing fistula.
  2. Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound
  3. Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
  4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op 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 US or intraoperatively) and which preclude adequate fit of the VasQ.
  6. Patients with prior 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 as evident from the patient's medical history
  11. Known allergy to nitinol
  12. Life expectancy less than 18 months
  13. Patients expected to undergo kidney transplant within 6 months of enrollment
  14. Women of child bearing potential 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: Daniella Bleistein, M.Sc. +972-3-6344246 ext 301 Daniella@laminatemedical.com
Contact: Uri Heiman, Dr. +972-3-6344246 ext 301 Uri@laminatemedical.com
Listed Location Countries  ICMJE France,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246984
Other Study ID Numbers  ICMJE CD0097
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 April 2019

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