VasQ External Support for Arteriovenous Fistula

Sponsor
Laminate Medical Technologies (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03242343
Collaborator
(none)
144
15
1
58.1
9.6
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VasQ
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
Actual Study Start Date :
Nov 29, 2017
Actual Primary Completion Date :
Oct 8, 2020
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: VasQ device implantation

Main 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.

Device: VasQ
An external support device for AV fistula

Outcome Measures

Primary Outcome Measures

  1. Primary Patency of AVF [6 months post AVF creation]

    Proportion of patients with freedom from intervention since device placement

  2. Occurrence of safety events [Device implantation to 6 months post AVF creation]

    The occurrence per patient access related safety events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Male and female participants.

  2. Age 18-80 years.

  3. 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.

  1. 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.

  1. 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.)

  2. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.

  3. Patients with central venous stenosis or obstruction on the side of surgery.

  4. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.

  5. Known coagulation disorder.

  6. Congestive heart failure NYHA class ≥ 3.

  7. Prior steal on the side of surgery.

  8. Known allergy to nitinol.

  9. Life expectancy less than 30 months.

  10. Patients expecting to undergo kidney transplant within 6 months of enrollment.

  11. Women of child bearing age without documented current negative pregnancy test.

  12. Inability to give consent and/or comply with the study follow up schedule.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grandview Medical Center Birmingham Alabama United States 35243
2 Arizona Kidney Disease & Hypertension Center Phoenix Arizona United States 85012
3 Saint Francis Medical Center Peoria Illinois United States 61637
4 Lutheran Medical Group/Indiana Ohio Heart Fort Wayne Indiana United States 46804
5 Brigham and Women's Hospital Boston Massachusetts United States 02115
6 Boston Medical Center Boston Massachusetts United States 02118
7 University of Michigan Ann Arbor Michigan United States 48109
8 Albany Medical College Albany New York United States 12208
9 Montefiore Medical Center New York New York United States 10467
10 Charlotte PA Charlotte North Carolina United States 28207
11 Duke University Medical Center Durham North Carolina United States 27710
12 Ohio State University Wexner Meidcal Center Columbus Ohio United States 43210
13 Greenville Health System Greenville South Carolina United States 29615
14 Cardiothoracic and Vascular Surgeons, P.A. Austin Texas United States 78756
15 Methodist DeBakey Heart and Vascular Center,The Methodist Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • Laminate Medical Technologies

Investigators

  • Study Director: Noam Zilberman, Laminate Medical Technologies Ltd.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Laminate Medical Technologies
ClinicalTrials.gov Identifier:
NCT03242343
Other Study ID Numbers:
  • CD0121
First Posted:
Aug 8, 2017
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021