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

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: Completed
• Conditions: Hemodialysis Access Failure
• Intervention / Treatment: Device: SurVeil Drug Coated Balloon

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)		30 days
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)		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.	Through 6 months
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)		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.	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.	6 months

Collaborators and Investigators

• Sponsor: SurModics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID 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