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External Support Device

VasQ for Aneurysm

N/A
Waitlist Available
Research Sponsored by Laminate Medical Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post avf creation
Awards & highlights

Study Summary

This trial will help to improve outcomes for arteriovenous fistulas by optimizing the configuration of the fistula and promoting laminar flow.

Eligible Conditions
  • Aneurysm
  • Arteriovenous Fistulas
  • Renal Disease
  • Takayasu's Arteritis
  • Kidney Failure
  • Kidney Disease
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post avf creation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post avf creation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of safety events
Primary Patency of AVF

Trial Design

1Treatment groups
Experimental Treatment
Group I: VasQ device implantationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VasQ
2014
N/A
~290

Find a Location

Who is running the clinical trial?

Laminate Medical TechnologiesLead Sponsor
3 Previous Clinical Trials
146 Total Patients Enrolled
Noam ZilbermanStudy DirectorLaminate Medical Technologies Ltd.
1 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of Vascular AccessJournal
Arteriovenous Fistula Construction with the Vasq™ External Support Device: A Pilot Study
Chemla, Eric, Carmen C. Velazquez, Fabrizio D'Abate, Veni Ramachandran, and Gary Maytham. 2016. “Arteriovenous Fistula Construction with the Vasq™ External Support Device: A Pilot Study”. The Journal of Vascular Access. SAGE Publications. doi:10.5301/jva.5000527.
clinicaltrials.govStudy
VasQ External Support for Arteriovenous Fistula
2017. "VasQ External Support for Arteriovenous Fistula". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03242343.
~20 spots leftby Apr 2025
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