Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis

Study Overview
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Brief Summary
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The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months.

Detailed Description
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To date, the treatment options are limited for recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas - Angioplasty, with or without the placement of a stent, surgical bypass using the internal jugular vein or a cephalic/brachial venous anastomosis, or the creation of a new fistula may be a reasonable option. Angioplasty may be associated with technical failure and rupture of the arch vein in reported incidences of 24% and 6%, respectively. Percutaneous Transluminal Angioplasty (PTA) is associated with very low primary patency rates of 42% and 23% at 6 and 12 months, whilst bare stents are equally poor, with reported patency of 39% and 0% at those same time-point. The use of a biomimetic stent (SUPERA®) in the cephalic arch has not been studied to date, but may not only offer protection from rupture of the arch vein but may also create a material barrier to prevent the development of Neo-Intimal Hyperplasia (NIH). With the additional use of drug elution, this may impede NIH effect even more.

Official Title
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Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis

Conditions
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Brachiocephalic Vein Stenosis

Intervention / Treatment
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* Device: Passeo-18 Lux and SUPERA® stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's age is above 21 and below 90 Informed consent obtained Chronic background treatment with daily ASA Patients with significant Cephalic Arch Vein Stenosis or recurrent stenosis within 6 months of initial POBA diagnosed either clinically or with Duplex Ultrasound Post-angioplasty cephalic arch lumen size between 5mm - 7mm maximum diameter Exclusion Criteria: Patients with significant central vein stenosis (>70%) or total occlusion at time of angiographic study Cephalic arch stenosis <50% stenosis or diameter >5mm Patients with previous cephalic arch stenting (Bare Metal Stents or stent graft) Concomitant fistula inflow problem (e.g. juxta-anastomotic) that cannot be corrected optimally during the intervention (>30% residual stenosis or angiographic lumen <3mm) Patients with minor or major cephalic arch rupture during POBA procedure and the rupture point cannot be adequately sealed off during the procedure requiring a covered stent or open conversion Cephalic arch lesion length <10mm or greater than 10cm Patients with uncontrolled hypertension Patient <21 or > 90 years of age. Pregnant women or women of childbearing potential who are not following an effective method of contraception. Contraindication to aspirin or clopidogrel usage Mental condition rendering the subject unable to understand the nature, scope, and possible consequences o the study, or language barrier such that the subject is unable to give informed consent. Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical Patients who do NOT have impaired renal function Occluded or thrombosed fistula Patients presenting with central venous stenosis Final angioplasty treatment requires a stent or DEB >7mm in diameter Multiple lesions in the access circuit that cannot be treated with one stent and DEB. Vascular access circuit placed in the lower extremities Bare metal stent or stent-graft placed previously Metastatic caner or terminal medical condition Blood coagulation disorder Limited life expectancy (<6 months) Sepsis or active infection Recent arm thrombophlebitis Allergy or other known contraindication to iodinated media contrast, heparin or paclitaxel

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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
Interventional Model Description: All subjects will be treated with SUPERA® stents and Passeo-18-Lux
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passeo-18 Lux and SUPERA® stent<br>Target lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty | Device: Passeo-18 Lux and SUPERA® stent<br>* Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Success | <30% regional stenosis within the stent and minimal lumen size should reach 5mm | Immediately post-operation | 
| Functional Fistula | At the following time points, to monitor for any changes in whether fistula can be used successfully for dialysis without the need for re-intervention. | Post-operation 1 week, 2 months, 6 months and 12 months. | 
| Primary Patency of Cephalic Arch | Less than 50% stenosis observed on duplex ultrasound | 1 year post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access Circuit Thrombosis | Thrombosis of access circuit requiring further intervention such as thrombolysis | 1 year post-operation | 
| Number of re-interventions per year | To note any re-interventions performed post-study procedure | 1 year post-operation | 
| Access Circuit Restenosis / Stent Fractures | To note any restenosis or stent fractures during study period that requires re-intervention | 1 year post-operation | 
| Access Circuit Infection | To note any infection at treated fistula during study period | 1 year post-operation | 
| Need for bypass revision surgery |  | 1 year post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis, Angioplasty, Vascular Disease