Catheter System Feasibility Clinical Trial

Study Overview
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Brief Summary
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Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.

Official Title
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Vessel-Select Catheter System Feasibility Clinical Trial

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Device: Percutaneous creation of an arteriovenous fistula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment Patients diagnosed with chronic kidney disease classification stage IV or V Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment Adequate quality radial artery >= 2 mm based on pre-operative assessment Adequate collateral arterial perfusion Radial artery-adjacent vein proximity < = 1.5 mm Able to provide informed consent Able to travel to institution for follow up examination Able to intraoperatively place an .014 guidewire in artery Exclusion Criteria: Suspected skin disease Immunocompromised patients (e.g. HIV positive) Edema of extremities Current diagnosis of carcinoma Pregnancy or currently breast feeding Diagnosed hypercoaguable state Active infection Evidence of vascular disease at target site Pre-existing vascular disease that could confound study results Vessel tortuosity or spasm preventing placement of .014 guidewire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment<br>Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula | Device: Percutaneous creation of an arteriovenous fistula<br>* Use of catheter system for percutaneous creation of an arteriovenous fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sufficient Patency for Clinical Access | Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate. | 6 weeks | 
| Number of Patients Achieving Dialysis Access | Arteriovenous fistula is mature and patient has started dialysis using the fistula | 6 weeks | 
| Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | The number of patients requiring additional interventions to achieve maturation and initiation of dialysis. | 12 weeks |