Clinical trial NCT03242343: VasQ External Support for Arteriovenous Fistula
Official title: A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterio-Venous Fistula
ESRD
Steal Syndrome
Aneurysm
Renal Failure
Renal Disease
Diabetes Mellitus
Kidney Failure
Lead sponsor: Laminate Medical Technologies
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 144
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 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male and female participants.
3. Age 18-80 years.
4. Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion Criteria:

1. Patients with the planned index procedure being a revision surgery of an existing fistula.
2. 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.
3. 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.
4. 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.)
5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
6. Patients with 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.
11. Known allergy to nitinol.
12. Life expectancy less than 30 months.
13. Patients expecting to undergo kidney transplant within 6 months of enrollment.
14. Women of child bearing age 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 AVF
timeFrame: 6 months post AVF creation
measure: Occurrence of safety events
timeFrame: Device implantation to 6 months post AVF creation
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Kidney Disease & Hypertension Center
state: Arizona
city: Peoria
country: United States
facility: Saint Francis Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Medical Group/Indiana Ohio Heart
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Charlotte PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Meidcal Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons, P.A.
state: Texas
city: Houston
country: United States
facility: Methodist DeBakey Heart and Vascular Center,The Methodist Hospital
state: Texas
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.