Clinical trial NCT03246984: VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
Official title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterio-Venous Fistula
Kidney Failure, Chronic
Kidney Diseases
Renal Failure Chronic
ESRD
Arteriovenous Fistula Thrombosis
Lead sponsor: Laminate Medical Technologies
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Primary patency of AV fistula
timeFrame: 6 months post AVF creation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Königin Elisabeth Krankenhaus Herzberge
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gemeinnützige GmbH
city: Wernigerode
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Laminate Medical Technologies Ltd.
name: Noam Zilberman
role: STUDY_DIRECTOR
References:
citation: 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.