Status:
COMPLETED
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
Lead Sponsor:
Laminate Medical Technologies
Conditions:
Arterio-Venous Fistula
Kidney Failure, Chronic
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
- Age 18-80 years
- Male and female participants
- Patients willing and able to attend follow up visits over a period of 12 months
Exclusion
- Patients with the planned index procedure being a revision surgery of an existing fistula.
- 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
- Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
- 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)
- Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
- Patients with prior central venous stenosis or obstruction on the side of surgery
- Depth of vein greater than 8 mm (on ultrasound) on side of surgery
- Known coagulation disorder
- Congestive heart failure NYHA class ≥ 3
- Prior steal on the side of surgery as evident from the patient's medical history
- Known allergy to nitinol
- Life expectancy less than 18 months
- Patients expected to undergo kidney transplant within 6 months of enrollment
- Women of child bearing potential without documented current negative pregnancy test
- Inability to give consent and/or comply with the study follow up schedule
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03246984
Start Date
September 7 2017
End Date
January 11 2021
Last Update
January 31 2024
Active Locations (11)
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1
Institut Mutualiste Montsouris
Paris, France, 75014
2
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
3
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
4
Königin Elisabeth Krankenhaus Herzberge
Berlin, Germany