VasQ External Support for Arteriovenous Fistula
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
1 other identifier
interventional
144
1 country
15
Brief Summary
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2022
CompletedOctober 6, 2023
October 1, 2023
2.9 years
August 3, 2017
October 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Patency of AVF
Proportion of patients with freedom from intervention since device placement
6 months post AVF creation
Occurrence of safety events
The occurrence per patient access related safety events
Device implantation to 6 months post AVF creation
Study Arms (1)
VasQ device implantation
EXPERIMENTALMain study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
Interventions
Eligibility Criteria
You may qualify if:
- Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.
- Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.
- Male and female participants.
- Age 18-80 years.
- Patients willing and able to attend follow up visits over a period of 24 months.
You may not qualify if:
- Patients with the planned index procedure being a revision surgery of an existing fistula.
- Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
- Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
- Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
- Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Patients with 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.
- Known allergy to nitinol.
- Life expectancy less than 30 months.
- Patients expecting to undergo kidney transplant within 6 months of enrollment.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, 85012, United States
Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Lutheran Medical Group/Indiana Ohio Heart
Fort Wayne, Indiana, 46804, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Albany Medical College
Albany, New York, 12208, United States
Montefiore Medical Center
New York, New York, 10467, United States
Charlotte PA
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University Wexner Meidcal Center
Columbus, Ohio, 43210, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
Cardiothoracic and Vascular Surgeons, P.A.
Austin, Texas, 78756, United States
Methodist DeBakey Heart and Vascular Center,The Methodist Hospital
Houston, Texas, 77030, United States
Related 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.
PMID: 27079670BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Noam Zilberman
Laminate Medical Technologies Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 8, 2017
Study Start
November 29, 2017
Primary Completion
October 8, 2020
Study Completion
April 3, 2022
Last Updated
October 6, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share