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

NCT03734679 | Completed Results FDA Device

• 1 other identifier: SUR18-001
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Hemodialysis Access Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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)

  30 days

Study Arms (1)

Surveil drug coated balloon

EXPERIMENTAL

Device: SurVeil Drug Coated Balloon

Interventions

SurVeil Drug Coated Balloon DEVICE

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Surveil drug coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Sites (2)

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Results Point of Contact

• Title: Thu Huyen Ha
• Organization: Surmodics

tha@surmodics.com

952.500.7261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: December 5, 2018
• Primary Completion: February 19, 2020
• Study Completion: July 24, 2024
• Last Updated: February 6, 2025
• Results First Posted: September 29, 2022

Record last verified: 2025-01

Locations

NZ (1); AU (1)