End Stage Renal DiseaseNCT04783779
Evaluation of STARgraft-2 for Hemodialysis Access
A study testing Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access in people with End Stage Renal Disease, run by Healionics Corporation at 1 site in Paraguay.
Trial summary
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteParaguay
- Study dates
- 16 Feb 2021to 31 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Axillary vein of greater than or equal to 7 mm in diameter.
- Brachial artery of greater than or equal to 4 mm in diameter.
- Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%)
- Systolic blood pressure equal to or greater than 120 mmHg.
- Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.
Who cannot join
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Clinically morbid obesity.
- Anatomical limitations.
- Immunodeficiency syndrome.
- History of bacterial infection within 8 weeks prior to graft implantation.
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- 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.
- Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.
This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included control implants of commercially available standard ePTFE grafts approved for the same use.
Read more
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:
- Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
- Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.
It is intended to enroll 25 subjects in this study.
- Conditions
- End Stage Renal Disease
- Being tested
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Keywords
- Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)
- 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.
Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis accessDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| STARgraft-2 | Experimental | Participants will be implanted with 6mm diameter STARgraft-2 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access. Receives: Device: Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Measured: 6 months post implantation.
Secondary outcomes (5)
Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Measured: 1, 2, 4, 9 and 12 months post implantation
Assisted Primary Patency
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
Measured: 1, 2, 4, 6, 9 and 12 months post implantation
Secondary Patency (Cumulative Patency)
Percentage of subjects without loss of access at the original implant site.
Measured: 1, 2, 4, 6, 9 and 12 months post implantation
Graft Related Infections
Frequency and severity of infections related to graft placement and use for dialysis access.
Measured: 1, 2, 4, 6, 9 and 12 months post implantation
Safety Outcomes
Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
Measured: 1, 2, 4, 6, 9 and 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start16 Feb 2021
- Primary completion1 Jun 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Model description
- All participants are implanted with the investigational grafts at a single site under consistent conditions. Study follow up examinations are performed at the same site. Routine dialysis procedures over the study period are performed at the participants established clinic.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healionics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Italian Hospital Asuncion Paraguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783779
- Sponsor's protocol ID
- CIP 00480 A
- Status last verified
- Feb 2024
- First submitted
- 2 Mar 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of STARgraft-2 for Hemodialysis Access
- ClinicalTrials.gov ID
- NCT04783779
- Acronym / sponsor ID
- CIP 00480 A
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Healionics CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Mar 2021 (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 study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.
This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included 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:
- Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
- Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.
It is intended to enroll 25 subjects in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are implanted with the investigational grafts at a single site under consistent conditions. Study follow up examinations are performed at the same site. Routine dialysis procedures over the study period are performed at the participants established clinic.
| Arm | Type | Receives |
|---|---|---|
| STARgraft-2 | Experimental | Device: Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis accessParticipants will be implanted with 6mm diameter STARgraft-2 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Clinically morbid obesity.
- Anatomical limitations.
- Immunodeficiency syndrome.
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 |
|---|---|---|
| Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis accessAfter 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. | Device | STARgraft-2 |
Primary outcome
Primary Unassisted Patency
Time frame: 6 months post implantation.
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
5 secondary outcomes
Primary Unassisted Patency
Time frame: 1, 2, 4, 9 and 12 months post implantation
Assisted Primary Patency
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Secondary Patency (Cumulative Patency)
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Graft Related Infections
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
Safety Outcomes
Time frame: 1, 2, 4, 6, 9 and 12 months post implantation
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 28 Feb 2024.
- 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.
Adrian Ebner, MD principal investigator
Italian Hospital Asuncion Paraguay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access in people with End Stage Renal Disease, run by Healionics Corporation at 1 site in Paraguay.
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 11 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 28 Feb 2024. 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 Paraguay. 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 Unassisted Patency (time frame: 6 months post implantation.). 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 28 Feb 2024.