VasQ External Support for Arteriovenous Fistula

Diabetes Mellitus Clinical Trial

Official title:

A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242343
• Other study ID #: CD0121
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: April 3, 2022

Study information

• Verified date: October 2023
• Source: Laminate Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 3, 2022
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Arterio-Venous Fistula
• Arteriovenous Fistula
• Diabetes Mellitus
• ESRD
• Fistula
• Kidney Failure
• Renal Disease
• Renal Failure
• Renal Insufficiency
• Steal Syndrome

Intervention

Device:
• VasQ
An external support device for AV fistula

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Cardiothoracic and Vascular Surgeons, P.A.	Austin	Texas
United States	Grandview Medical Center	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Charlotte PA	Charlotte	North Carolina
United States	Ohio State University Wexner Meidcal Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Lutheran Medical Group/Indiana Ohio Heart	Fort Wayne	Indiana
United States	Greenville Health System	Greenville	South Carolina
United States	Methodist DeBakey Heart and Vascular Center,The Methodist Hospital	Houston	Texas
United States	Montefiore Medical Center	New York	New York
United States	Saint Francis Medical Center	Peoria	Illinois
United States	Arizona Kidney Disease & Hypertension Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Laminate Medical Technologies

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency of AVF	Proportion of patients with freedom from intervention since device placement	6 months post AVF creation
Primary	Occurrence of safety events	The occurrence per patient access related safety events	Device implantation to 6 months post AVF creation

External Links

•   Related Info