Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Study Overview
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Brief Summary
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A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.

Official Title
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Ellipsys Vascular Access Catheter System Clinical Trial

Conditions
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AV Fistula, End Stage Renal Disease, Fistula, End Stage Kidney Disease

Intervention / Treatment
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* Device: Ellipsys Vascular Access Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible for enrollment into the study if they met the following criteria: Patients ≥ 18 years of age and ≤ 80 years of age Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential) Life expectancy of at least one year, per the investigator's opinion Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein based on pre-operative assessment Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site Confirmed clinically significant outflow Adequate quality radial artery based on pre-operative assessment a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site Adequate collateral arterial perfusion Patent palmar arch Negative Allen's Test for ulnar artery insufficiency No clinical evidence of subclavian artery stenosis on the ipsilateral side. Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure Patient was able to provide written informed consent Able to travel to enrolling institution for follow-up examinations Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15) Exclusion Criteria: Patients were excluded if any of the following was true: Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%) a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side Pre-existing vascular disease that could confound the study results Systolic pressures < 100 mm Hg at the time of screening Suspected or confirmed skin disease at the skin entry site Immunocompromised patients (e.g. HIV positive) Edema of the upper extremity on the ipsilateral side Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3 Current diagnosis of carcinoma (defined as in remission < 1 year) Pregnant or currently breast feeding Known bleeding diathesis or coagulation disorder Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy Patients with acute or active infection Scheduled kidney transplant within 6 months of enrollment Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form) History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment Patient required creation of an arteriovenous fistula distal to the wrist Patient required nerve block requiring immobilization of the arm

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: Ellipsys Vascular Access Catheter<br>ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. | Device: Ellipsys Vascular Access Catheter<br>* A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation Success Rate at 90 Days | Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population. | 90 days | 
| Number of Participants With Device-related Serious Adverse Events | The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Access Systems That Successfully Created an AVF | Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment | 90 days | 
| Percent of Access Sites With Clinical Patency at Discharge | Percent of access sites that demonstrated physical exam patency through clinic discharge | 90 days | 
| Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days | Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation | 90 days | 
| Percent of Access Sites That Achieved or Maintained Maturation at 90 Days | Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency. | 90 days | 
| Percent of Access Sites That Achieved Maturation Without Intervention | Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation | 90 days | 
| Percent of Access Sites That Were Patent Following Intervention | Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency | 90 days | 
| Percent of Access Sites That Achieved Patency Without Intervention | Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site | 90 days | 
| Intervention Rate | Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site | 90 days | 
| Transposition Rate | Percent of subjects who required one or more surgical transpositions performed to facilitate needle access | 90 days |