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

Not Applicable

Completed

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.

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Surveil drug coated balloon	SurVeil Drug Coated Balloon	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure	6 months	Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Secondary Functional Patency	Through 6 months	Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)	6 months	Patency is defined as \<50% restenosis within the target lesion.
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)	30 days
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)	30 days
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