Arterio-Venous FistulaVALUENCT03246984
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
A study testing VasQ in people with Arterio-Venous Fistula and Kidney Failure, Chronic, run by Laminate Medical Technologies at 11 sites in 4 countries.
Trial summary
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases
- What is being tested?
- VasQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 7 Sep 2017to 11 Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
- Age 18-80 years
- Male and female participants
- Patients willing and able to attend follow up visits over a period of 12 months
Who cannot join
- Patients with the planned index procedure being a revision surgery of an existing fistula.
- Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound
- Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein)
- Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
- Patients with prior central venous stenosis or obstruction on the side of surgery
Show all 15Show fewer
- Depth of vein greater than 8 mm (on ultrasound) on side of surgery
- Known coagulation disorder
- Congestive heart failure NYHA class ≥ 3
- Prior steal on the side of surgery as evident from the patient's medical history
- Known allergy to nitinol
- Life expectancy less than 18 months
- Patients expected to undergo kidney transplant within 6 months of enrollment
- Women of child bearing potential without documented current negative pregnancy test
- Inability to give consent and/or comply with the study follow up schedule
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany8 sites
Universitätsklinikum Augsburg
Augsburg, 86156
Charité - Universitätsmedizin Berlin
Berlin, 13353
Königin Elisabeth Krankenhaus Herzberge
Berlin
Klinikum Chemnitz gGmbH
Chemnitz, 09113
University Hospital Cologne
Cologne, 50937
Universitaetsklinikum Jena
Jena
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, 14467
Harzklinikum Dorothea Christiane Erxleben
Wernigerode
About this study
Official title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
- Conditions
- Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Failure Chronic, ESRD, Arteriovenous Fistula Thrombosis
- Being tested
- VasQ
- Medical subject headings
- Arteriovenous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasQDevice
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
| Study group | Role | What they receive |
|---|---|---|
| VasQ device implantation | Experimental | Not described Receives: Device: VasQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of AV fistula
Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US.
1 = Success = Intervention free access patency determined by Doppler ultrasound.
0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
Measured: 6 months post AVF creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start7 Sep 2017
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
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 Arterio-Venous FistulaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laminate Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Zilberman, Study director, Laminate Medical Technologies Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246984
- Sponsor's protocol ID
- CD0097
- Acronym
- VALUE
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2017
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27079670
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT03246984
- Acronym / sponsor ID
- VALUE / CD0097
- Conditions
- Arterio-Venous Fistula, Kidney Failure, Chronic, Kidney Diseases, Renal Failure Chronic, ESRD, Arteriovenous Fistula Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laminate Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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 is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VasQ device implantation | Experimental | Device: VasQ |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for creation of a new brachiocephalic or radiocephalic fistula who consent to take part in the study.
- Age 18-80 years
- Male and female participants
- Patients willing and able to attend follow up visits over a period of 12 months
Key exclusion criteria (15 listed)
- Patients with the planned index procedure being a revision surgery of an existing fistula.
- Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound
- Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on pre-op ultrasound (scan should include the area between the planned anastomosis site and the Axillary vein)
- Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
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 |
|---|---|---|
| VasQVasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation. | Device | VasQ device implantation |
Primary outcome
Primary patency of AV fistula
Time frame: 6 months post AVF creation
Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
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 31 Jan 2024.
- Background: PubMed 27079670Chemla 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Noam Zilberman study director
Laminate Medical Technologies Ltd.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VasQ in people with Arterio-Venous Fistula and Kidney Failure, Chronic, run by Laminate Medical Technologies at 11 sites in 4 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 15 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, France, Spain, United Kingdom. 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 patency of AV fistula (time frame: 6 months post AVF creation). 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 NCT03246984, 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 31 Jan 2024.