VasQ External Support for Arteriovenous Fistula

• ClinicalTrials.gov Identifier: NCT03242343
• Recruitment Status: Active, not recruiting
• First Posted: August 8, 2017
• Last Update Posted: October 27, 2020
• Sponsor: Laminate Medical Technologies
• Information provided by (Responsible Party): Laminate Medical Technologies

Tracking Information

• First Submitted Date: August 3, 2017
• First Posted Date: August 8, 2017
• Last Update Posted Date: October 27, 2020
• Actual Study Start Date: November 29, 2017
• Actual Primary Completion Date: October 8, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2017)

• Primary Patency of AVF [ Time Frame: 6 months post AVF creation ]
  Proportion of patients with freedom from intervention since device placement
• Occurrence of safety events [ Time Frame: Device implantation to 6 months post AVF creation ]
  The occurrence per patient access related safety events

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Device: VasQ

An external support device for AV fistula

Study Arms

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.

Intervention: Device: VasQ

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 18, 2019): 144
• Original Estimated Enrollment (submitted: August 3, 2017): 129
• Estimated Study Completion Date: October 2022
• Actual Primary Completion Date: October 8, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03242343
• Other Study ID Numbers: CD0121
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Laminate Medical Technologies
• Study Sponsor: Laminate Medical Technologies
• Collaborators: Not Provided

Investigators

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

• PRS Account: Laminate Medical Technologies
• Verification Date: October 2020