- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916731
Evaluation of STARgraft AV for Hemodialysis Access
First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis.
Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use.
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:
- Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year.
- Verify safety of the STARgraft AV multilayer construction in extended vascular access use.
It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Asunción, Paraguay
- Italian Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, > 18 years or age.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Able to effectively communicate with study personnel.
- Candidate for a new arterio-venous graft placed in the upper arm.
- Life expectancy judged to be at least 2 years.
- Axillary vein of greater than or equal to 7 mm in diameter.
- Brachial artery of greater than or equal to 4 mm in diameter.
- Systolic blood pressure equal to or greater than 120 mmHg.
- Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or angiogram.
Exclusion Criteria:
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Clinical morbid obesity.
- Anatomical limitations.
- Immunodeficiency syndrome.
- History of bacterial infection within 8 weeks prior to graft implantation.
- History of hypercoagulation or bleeding disorders.
- Elevated platelet count > 1 million per microliter of blood.
- History of heparin-induced thrombocytopenia syndrome (HIT).
- Medically confirmed stenosis of the veins downstream of the implant site.
- Inadequate arterial flow or pressure proximal to the implant site.
- Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
- Fever greater than 38° C.
- Prior allergic reaction to silicone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STARgraft AV
Participants will be implanted with 6mm diameter STARgraft AV grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
|
Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access.
After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions.
Periodic evaluations of blood flow by ultrasound imaging will be made over the study period.
Established standards of care will be followed as needed to maintain dialysis function.
|
Active Comparator: Control (ePTFE)
Participants will be implanted in the same upper arm location with standard 6mm diameter ePTFE dialysis access grafts.
All other aspects of this study arm are identical to the Experimental one.
|
Implant of standard ePTFE AV shunt as a control in the upper arm and subsequent use for hemodialysis access.
After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions.
Periodic evaluations of blood flow by ultrasound imaging will be made over the study period.
Established standards of care will be followed as needed to maintain dialysis function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Unassisted Patency
Time Frame: 12 months post implantation.
|
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
|
12 months post implantation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Unassisted Patency
Time Frame: 1, 2, 4, 9 and 12 months post implantation
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Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
|
1, 2, 4, 9 and 12 months post implantation
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Assisted Primary Patency
Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
|
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
|
1, 2, 4, 6, 9 and 12 months post implantation
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Secondary Patency (Cumulative Patency)
Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
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Percentage of subjects without loss of access at the original implant site.
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1, 2, 4, 6, 9 and 12 months post implantation
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Safety Outcomes
Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
|
Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
|
1, 2, 4, 6, 9 and 12 months post implantation
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Graft Related Infections
Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
|
Frequency of infections related to graft placement and use for dialysis access.
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1, 2, 4, 6, 9 and 12 months post implantation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Systolic Velocity (PSV) Ratio
Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation
|
Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)
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2 weeks and 1, 2, 4, 6, 9, 12 months post implantation
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Blood flow rates in grafts.
Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
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Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation
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2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP 00355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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