Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

January 23, 2025 updated by: SurModics, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Private Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must be ≥18 years of age.
  2. Native AV fistula has been created ≥60 days prior to the index procedure.
  3. AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.
  4. Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.
  5. Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.
  6. Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.
  7. 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
  8. Subject has provided written informed consent and is willing to comply with study follow-up requirements.
  9. Subject has a life expectancy of ≥1 year

Exclusion Criteria:

  1. Subject has a synthetic AV graft.
  2. Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.
  3. Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.
  4. Target lesion is located <30 mm from any stent.
  5. Thrombosis of the access site 30 days prior to procedure.
  6. Surgical revision of the access site planned within 30 days of procedure.
  7. Blood coagulative disorder, sepsis, or current AV access infection (white blood count ≥12,000).
  8. 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.
  9. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day.
  10. Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post procedure.
  11. Myocardial infarction 30 days prior to procedure.
  12. Stroke or TIA 90 days prior to procedure.
  13. Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.
  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Surveil drug coated balloon
Device: SurVeil Drug Coated Balloon
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)
Time Frame: 30 days
30 days
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)
Time Frame: 30 days
30 days
Number of Participants With Secondary Functional Patency
Time Frame: Through 6 months
Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.
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
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
Patency is defined as <50% restenosis within the target lesion.
30 days
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Time Frame: 6 months
Patency is defined as <50% restenosis within the target lesion.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SurModics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SUR18-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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