Hemodialysis Access FailureNCT03734679
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
A study testing SurVeil Drug Coated Balloon in people with Hemodialysis Access Failure, run by SurModics, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- SurVeil Drug Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Dec 2018to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must be ≥18 years of age.
- Native AV fistula has been created ≥60 days prior to the index procedure.
- AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
- Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
- Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
- Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.
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- Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND pre-dilatation with a PTA balloon resulting in: residual stenosis of ≤30% and dissection ≤ Grade B
- Subject has provided written informed consent and is willing to comply with study follow-up requirements.
- Subject has a life expectancy of ≥1 year
Who cannot join
- Subject has a synthetic AV graft.
- Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.
- Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.
- Target lesion is located <30 mm from any stent.
- Thrombosis of the access site 30 days prior to procedure.
- Surgical revision of the access site planned within 30 days of procedure.
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- Blood coagulative disorder, sepsis, or current AV access infection (white blood count ≥12,000).
- Known contraindication (including allergic reaction) or sensitivity to antiplatelet therapy, anticoagulation therapy or paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication.
- Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day.
- Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post procedure.
- Myocardial infarction 30 days prior to procedure.
- Stroke or TIA 90 days prior to procedure.
- Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.
- Subject is participating in any other investigational study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoint from this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
About this study
Official title: A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
Read the detailed description
AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects
- Conditions
- Hemodialysis Access Failure
- Being tested
- SurVeil Drug Coated Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurVeil Drug Coated BalloonDevice
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
| Study group | Role | What they receive |
|---|---|---|
| Surveil drug coated balloon | Experimental | Not described Receives: Device: SurVeil Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
Measured: 6 months
Secondary outcomes (6)
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)
Measured: 30 days
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)
Measured: 30 days
Number of Participants With Secondary Functional Patency
Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.
Measured: Through 6 months
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)
Measured: 30 days and 6 months
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Patency is defined as <50% restenosis within the target lesion.
Measured: 30 days
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Patency is defined as <50% restenosis within the target lesion.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start5 Dec 2018
- Primary completion19 Feb 2020
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemodialysis Access FailureStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- SurModics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734679
- Sponsor's protocol ID
- SUR18-001
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2018
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts
- ClinicalTrials.gov ID
- NCT03734679
- Acronym / sponsor ID
- SUR18-001
- Conditions
- Hemodialysis Access Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SurModics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
Detailed description
AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surveil drug coated balloon | Experimental | Device: SurVeil Drug Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be ≥18 years of age.
- Native AV fistula has been created ≥60 days prior to the index procedure.
- AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
- Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
- Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
Key exclusion criteria (14 listed)
- Subject has a synthetic AV graft.
- Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.
- Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.
- Target lesion is located <30 mm from any stent.
- Thrombosis of the access site 30 days prior to procedure.
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 |
|---|---|---|
| SurVeil Drug Coated BalloonAngioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. | Device | Surveil drug coated balloon |
Primary outcome
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
Time frame: 6 months
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
6 secondary outcomes
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)
Time frame: 30 days
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)
Time frame: 30 days
Number of Participants With Secondary Functional Patency
Time frame: Through 6 months
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)
Time frame: 30 days and 6 months
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Time frame: 30 days
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurVeil Drug Coated Balloon in people with Hemodialysis Access Failure, run by SurModics, Inc. at 2 sites in 2 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 9 inclusion and 14 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure (time frame: 6 months). 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 6 Feb 2025.