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

Kidney Diseases Clinical Trial

— VALUE  

Official title:

A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246984
• Other study ID #: CD0097
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: January 11, 2021

Study information

• Verified date: January 2024
• Source: Laminate Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterio-Venous Fistula
• Arteriovenous Fistula
• Arteriovenous Fistula Thrombosis
• ESRD
• Fistula
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency
• Thrombosis

Intervention

Device:
• VasQ
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris
Germany	Universitätsklinikum Augsburg	Augsburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Königin Elisabeth Krankenhaus Herzberge	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	University Hospital Cologne	Cologne
Germany	Universitaetsklinikum Jena	Jena
Germany	Klinikum Ernst von Bergmann gemeinnützige GmbH	Potsdam
Germany	Harzklinikum Dorothea Christiane Erxleben	Wernigerode
Spain	Hospital Clinic of Barcelona	Barcelona
United Kingdom	Guy's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Laminate Medical Technologies

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency of AV fistula	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	6 months post AVF creation

External Links

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