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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03242343
Other study ID # CD0121
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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