CompletedNot Applicable

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

Australia, New Zealand12 participantsStarted 2018-12-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure

Timeframe: 6 months

Trial details

NCT IDNCT03734679

SponsorSurModics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-19

Results submitted2022-08-11

View on ClinicalTrials.gov More Hemodialysis Access Failure trials