Vascular AccessNCT02112669
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
A study testing VasQ in people with Vascular Access and End Stage Renal Disease, run by Laminate Medical Technologies at 4 sites in 2 countries.
Trial summary
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vascular Access, End Stage Renal Disease
- What is being tested?
- VasQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
- Aged > 18
- Male and female participants
- Patients willing and able to attend follow up visits over a period of 6 months
Who cannot join
- Patients who require revision surgery.
- Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
- Target arteries smaller than 3 mm in diameter
- Target vein smaller than 3 mm in diameter
- Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
- Patients with prior central venous stenosis or obstruction on the side of surgery
Show all 13Show fewer
- Depth of vein greater than 8 mm (on US) on side of surgery
- Known coagulation disorder
- Prior steal
- Known allergy to nitinol
- Life expectancy less than 6 months
- Inability to give consent and/or comply with the study follow up schedule
- Women of child bearing age
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Southmead Hospital
Bristol, BS10 5NB
Guy's Hospital
London, SE1 9RT
St George's Healthcare
London
About this study
Official title: A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.
- Conditions
- Vascular Access, End Stage Renal Disease
- Being tested
- VasQ
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasQDevice
| Study group | Role | What they receive |
|---|---|---|
| AV fistula with VasQ | Experimental | Implant VasQ over AV fistula Receives: Device: VasQ |
| AV fistula | No intervention | AV fistula without any adjunct device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
Measured: 6 months
Secondary outcomes (4)
Secondary efficacy endpoint: Percentage of AVF physiologically matured
Successful physiological maturation was defined by a minimum of 5 mm cephalic vein diameter with volume outflow greater than 500 mL/min confirmed by color duplex spectral analysis
Measured: 3 months
Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
Measured: 6 months
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Measured: 1, 3, and 6 months
Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laminate Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112669
- Sponsor's protocol ID
- Laminate CD0006
- Status last verified
- Jun 2019
- First submitted
- 10 Apr 2014
- Last updated
- 6 Jun 2019
- Results posted
- No
Publications
Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M, Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53. doi: 10.1053/j.ajkd.2019.05.023. Epub 2019 Aug 22.
PubMed 31447072
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT02112669
- Acronym / sponsor ID
- Laminate CD0006
- Conditions
- Vascular Access, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laminate Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AV fistula with VasQ | Experimental | Device: VasQImplant VasQ over AV fistula |
| AV fistula | No intervention | –AV fistula without any adjunct device |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
- Aged > 18
- Male and female participants
- Patients willing and able to attend follow up visits over a period of 6 months
Key exclusion criteria (13 listed)
- Patients who require revision surgery.
- Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
- Target arteries smaller than 3 mm in diameter
- Target vein smaller than 3 mm in diameter
- Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasQ | Device | AV fistula with VasQ |
Primary outcome
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events
Time frame: 6 months
4 secondary outcomes
Secondary efficacy endpoint: Percentage of AVF physiologically matured
Time frame: 3 months
Secondary efficacy endpoint: Primary patency of the study AVF, defined as percentage of patent AVF free from surgical or endovascular interventions
Time frame: 6 months
Secondary efficacy endpoint: Cephalic vein outflow as assess with Doppler ultrasound
Time frame: 1, 3, and 6 months
Secondary efficacy endpoint: Secondary patency of the study AVF, defined as percentage of patent AVF following surgical or endovascular interventions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 31447072Karydis N, Bevis P, Beckitt T, Silverberg D, Halak M, Calder F. An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):45-53. doi: 10.1053/j.ajkd.2019.05.023. Epub 2019 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VasQ in people with Vascular Access and End Stage Renal Disease, run by Laminate Medical Technologies at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.