FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)

Inclusion Criteria

• Patient is ≥21 years of age.
• Patient has a life expectancy of ≥12 months.
• Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
• The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
• Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.
• Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).

Note: Tandem lesions may be enrolled provided they meet all of the following criteria:

• Separated by a gap of ≤ 30mm (3 cm).
• Total combined lesion length, including 30 mm gap, ≤ 100 mm.
• Able to be treated as a single lesion.
• Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
• Patient underwent successful crossing of the target lesion with the guidewire.
• Patient provides written informed consent prior to enrollment in the study.
• Patient is willing to comply with all follow-up evaluations at specified times.

Exclusion Criteria

• Patient is pregnant or breastfeeding.
• Patient is receiving immunosuppressive therapy.
• Patient has undergone prior intervention of access site within 30 days of index procedure.
• Patient with anticipated conversion to peritoneal dialysis.
• Patient has an infected AV access or systemic infection.
• Patient has planned surgical revision of access site.
• Patient with secondary non-target lesion requiring treatment within 30 days post index procedure.
• Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
• Patient with target AVF or access circuit which previously had thrombectomy within last 30 days.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
• Patient with target lesion located central to the axillosubclavian junction.
• Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access.
• Patient has presence of pseudoaneurysm or aneurysm requiring surgical revision at the target lesion site.
• Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated.
• Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy.
• Patient with clinically significant Steal Syndrome requiring treatment.
• Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint or was previously enrolled in this study.
• Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation.
• Patient has AV fistula created via endovascular technique.