VasQ External Support for Arteriovenous Fistula
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03242343 |
Recruitment Status :
Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : October 27, 2020
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 3, 2017 | ||||||
First Posted Date ICMJE | August 8, 2017 | ||||||
Last Update Posted Date | October 27, 2020 | ||||||
Actual Study Start Date ICMJE | November 29, 2017 | ||||||
Actual Primary Completion Date | October 8, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | VasQ External Support for Arteriovenous Fistula | ||||||
Official Title ICMJE | 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. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: VasQ
An external support device for AV fistula
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Study Arms ICMJE | 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
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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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
144 | ||||||
Original Estimated Enrollment ICMJE |
129 | ||||||
Estimated Study Completion Date ICMJE | October 2022 | ||||||
Actual Primary Completion Date | October 8, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03242343 | ||||||
Other Study ID Numbers ICMJE | CD0121 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Laminate Medical Technologies | ||||||
Study Sponsor ICMJE | Laminate Medical Technologies | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Laminate Medical Technologies | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |