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Trial record 81 of 34170 for:    value

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

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.

Condition or disease Intervention/treatment Phase
Arterio-Venous Fistula Kidney Failure, Chronic Kidney Diseases Renal Failure Chronic ESRD Arteriovenous Fistula Thrombosis Device: VasQ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: VasQ device implantation Device: VasQ
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.




Primary Outcome Measures :
  1. 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




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. 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

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): NCT03246984


Contacts
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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

Locations
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France
Institut Mutualiste Montsouris Not yet recruiting
Paris, France, 75014
Contact: Alexandros Mallios, MD         
Germany
Universitätsklinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Alexander Hyhlik-Dürr, MD         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Königin Elisabeth Krankenhaus Herzberge Recruiting
Berlin, Germany
Contact: Hans Scholz, PD Dr. med.         
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09113
Contact: Sven Seifert, Dr. med.         
University Hospital Cologne Recruiting
Cologne, Germany, 50937
Contact: Jan Brunkwall, Dr. med.         
Elisabeth-Krankenhaus Essen Withdrawn
Essen, Germany
Universitaetsklinikum Jena Recruiting
Jena, Germany
Contact: Juergen Zanow, PD Dr.         
Klinikum Ernst von Bergmann gemeinnützige GmbH Recruiting
Potsdam, Germany, 14467
Contact: Peter Olschewski, Dr. med.         
Harzklinikum Dorothea Christiane Erxleben Recruiting
Wernigerode, Germany
Contact: Torsten Mildner, Dr.         
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Gaspar Mestres, Dr.         
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Nikolaos Karydis, MD         
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: NCT03246984     History of Changes
Other Study ID Numbers: CD0097
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
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: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Thrombosis
Arteriovenous Fistula
Fistula
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Vascular Fistula
Congenital Abnormalities
Renal Insufficiency, Chronic