VasQ and Hemodynamic Conditions in AVFs (RESHAPE)
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Implantation of VasQ device
Sponsored by
About this trial
This is an interventional device feasibility trial for Renal Insufficiency, Chronic focused on measuring artero-venous fistula, non-Contrast Enhanced MRI, hemodynamics, CFD simulations, VasQ
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AVF surgery with device
AVF surgery conventional
Arm Description
Outcomes
Primary Outcome Measures
Wall shear stress in AVFs.
Hemodynamic parameter (wall shear stress) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Oscillatory shear index in AVFs.
Hemodynamic parameter (oscillatory shear index) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Secondary Outcome Measures
Full Information
NCT ID
NCT04141852
First Posted
October 11, 2019
Last Updated
November 24, 2021
Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Laminate Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT04141852
Brief Title
VasQ and Hemodynamic Conditions in AVFs
Acronym
RESHAPE
Official Title
Arterovenous Fistula Surgery With the VasQ Support Device: The Effects on Hemodynamic Conditions - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Laminate Medical Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
artero-venous fistula, non-Contrast Enhanced MRI, hemodynamics, CFD simulations, VasQ
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AVF surgery with device
Arm Type
Experimental
Arm Title
AVF surgery conventional
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Implantation of VasQ device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wall shear stress in AVFs.
Description
Hemodynamic parameter (wall shear stress) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Time Frame
Changes from 3 days after surgery and 40 days after surgery.
Title
Oscillatory shear index in AVFs.
Description
Hemodynamic parameter (oscillatory shear index) obtained by combining MRI acquisition/ processing and computational fluid dynamics.
Time Frame
Changes from 3 days after surgery and 40 days after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
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
City
Bergamo
State/Province
BG
ZIP/Postal Code
24100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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VasQ and Hemodynamic Conditions in AVFs
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