Renal Insufficiency, ChronicRESHAPENCT04141852
VasQ and Hemodynamic Conditions in AVFs
A study testing Implantation of VasQ device in people with Renal Insufficiency, Chronic, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Implantation of VasQ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2019to 22 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 75 years
- Patients that entered the pre-dialysis program because of ESRD
- Patients in need of a new VA for HD treatment
- Treatment of first choice is creation of a distal autogenous AVF
- Written informed consent
Who cannot join
- Contraindication for creating an autogenous AVF
- Life expectancy less than 1 year
- Prior VA, central venous stenosis or obstructions in the arm selected for AVF surgery
- Patient not suitable for MRI examination (ferro-magnetic prosthesis, pacemaker, aneurysm clips, obesity, spastic paralysis, severe claustrophobia or other contraindications or exclusions interfering with MRI)
- Unusual anatomy or vessel dimensions (observed on pre-operative US or intraoperatively) and which preclude adequate fit of the VasQ.
- Depth of vein greater than 8 mm (on ultrasound) on side of surgery
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- Known coagulation disorder
- Known allergy to nitinol
- Patients expected to undergo kidney transplant within 12 months of enrollment
- Females who are pregnant or planning to become pregnant during the study
- Inability to give consent and/or comply with the study follow up schedule
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò
Bergamo, BG, 24100
About this study
Official title: Arterovenous Fistula Surgery With the VasQ Support Device: The Effects on Hemodynamic Conditions - Pilot Study
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functional vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. To date, VA dysfunction is the major cause of morbidity and hospitalisation in HD patients, and the major limitation of HD treatment. The current recommendation for VA is the native artero-venous fistula (AVF), surgically created in the forearm, but is still affected by high non-maturation and early failure rates. The most common cause of AVF early-failure is vascular stenosis due to neointimal hyperplasia (NH). Despite the exact mechanisms underlying stenosis development remain tentative, there is general consensus that hemodynamic conditions play a key role in the formation of NH. Previous computational fluid dynamics (CFD) investigations inside patient-specific AVF models conducted by our group revealed transitional laminar-to-turbulent flow in the juxta-anastomotic vein.
Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF. The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow.
Read more
VasQ attempts at constraining and shaping geometrical parameters of the AVF, as well as reinforcing the vulnerable perianastomotic vein against high pressure, wall tension and flow levels. A prospective single-centre study demonstrated the safety of the VasQ external support device, but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated.
A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI (NCE-MRI) and high-resolution CFD simulations, using a NCE-MRI protocol recently optimized by our group. Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition. Combined with high-resolution CFD, our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints, immediately after AVF surgery and at AVF maturation. Therefore, it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions, as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Implantation of VasQ device
- Keywords
- artero-venous fistula, non-Contrast Enhanced MRI, hemodynamics, CFD simulations, VasQ
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of VasQ deviceDevice
The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow.
| Study group | Role | What they receive |
|---|---|---|
| AVF surgery with device | Experimental | Not described Receives: Device: Implantation of VasQ device |
| AVF surgery conventional | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wall shear stress in AVFs.
Hemodynamic parameter (wall shear stress) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Measured: Changes from 3 days after surgery and 40 days after surgery.
Oscillatory shear index in AVFs.
Hemodynamic parameter (oscillatory shear index) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Measured: Changes from 3 days after surgery and 40 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start11 Oct 2019
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laminate Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141852
- Sponsor's protocol ID
- RESHAPE
- Acronym
- RESHAPE
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2019
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterovenous Fistula Surgery With the VasQ Support Device: The Effects on Hemodynamic Conditions - Pilot Study
- ClinicalTrials.gov ID
- NCT04141852
- Acronym / sponsor ID
- RESHAPE / RESHAPE
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- artero-venous fistula, non-Contrast Enhanced MRI, hemodynamics, CFD simulations, VasQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Laminate Medical Technologies
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 28 Oct 2019 (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.
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functional vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. To date, VA dysfunction is the major cause of morbidity and hospitalisation in HD patients, and the major limitation of HD treatment. The current recommendation for VA is the native artero-venous fistula (AVF), surgically created in the forearm, but is still affected by high non-maturation and early failure rates. The most common cause of AVF early-failure is vascular stenosis due to neointimal hyperplasia (NH). Despite the exact mechanisms underlying stenosis development remain tentative, there is general consensus that hemodynamic conditions play a key role in the formation of NH. Previous computational fluid dynamics (CFD) investigations inside patient-specific AVF models conducted by our group revealed transitional laminar-to-turbulent flow in the juxta-anastomotic vein.
Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF. The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow.
VasQ attempts at constraining and shaping geometrical parameters of the AVF, as well as reinforcing the vulnerable perianastomotic vein against high pressure, wall tension and flow levels. A prospective single-centre study demonstrated the safety of the VasQ external support device, but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated.
A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI (NCE-MRI) and high-resolution CFD simulations, using a NCE-MRI protocol recently optimized by our group. Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition. Combined with high-resolution CFD, our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints, immediately after AVF surgery and at AVF maturation. Therefore, it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions, as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVF surgery with device | Experimental | Device: Implantation of VasQ device |
| AVF surgery conventional | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years and < 75 years
- Patients that entered the pre-dialysis program because of ESRD
- Patients in need of a new VA for HD treatment
- Treatment of first choice is creation of a distal autogenous AVF
- Written informed consent
Key exclusion criteria (11 listed)
- Contraindication for creating an autogenous AVF
- Life expectancy less than 1 year
- Prior VA, central venous stenosis or obstructions in the arm selected for AVF surgery
- Patient not suitable for MRI examination (ferro-magnetic prosthesis, pacemaker, aneurysm clips, obesity, spastic paralysis, severe claustrophobia or other contraindications or exclusions interfering with MRI)
- 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 |
|---|---|---|
| Implantation of VasQ deviceThe VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and "hugging" the artery near the junction site, without being in contact with the blood flow. | Device | AVF surgery with device |
Primary outcome
Wall shear stress in AVFs.
Time frame: Changes from 3 days after surgery and 40 days after surgery.
Hemodynamic parameter (wall shear stress) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Oscillatory shear index in AVFs.
Time frame: Changes from 3 days after surgery and 40 days after surgery.
Hemodynamic parameter (oscillatory shear index) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
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 26 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of VasQ device in people with Renal Insufficiency, Chronic, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 5 inclusion and 11 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Wall shear stress in AVFs. (time frame: Changes from 3 days after surgery and 40 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2021.