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

Not Applicable

Completed

• Conditions: Arteriovenous Fistula Thrombosis; Arterio-Venous Fistula; ESRD; Kidney Diseases; Renal Failure Chronic; Kidney Failure, Chronic
• Interventions: Device: VasQ

• Registration Number: NCT03246984
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Study Start: 2017-09-07
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VasQ device implantation	VasQ	-

Primary Outcome Measures

Name	Time	Method
Primary patency of AV fistula	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

Trial Locations

Locations (11)

Universitaetsklinikum Jena; 🇩🇪 Jena, Germany

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Königin Elisabeth Krankenhaus Herzberge; 🇩🇪 Berlin, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Klinikum Ernst von Bergmann gemeinnützige GmbH; 🇩🇪 Potsdam, Germany

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Harzklinikum Dorothea Christiane Erxleben; 🇩🇪 Wernigerode, Germany

University Hospital Cologne; 🇩🇪 Cologne, Germany

Guy's Hospital; 🇬🇧 London, United Kingdom