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

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

Official Title
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A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts

Conditions
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Hemodialysis Access Failure

Intervention / Treatment
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* Device: SurVeil Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surveil drug coated balloon<br> | Device: SurVeil Drug Coated Balloon<br>* Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months. | 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) | Patency is defined as <50% restenosis within the target lesion. | 30 days | 
| Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab) | Patency is defined as <50% restenosis within the target lesion. | 6 months |