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

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

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.
• Subject has a life expectancy of ≥1 year

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.
• 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.