Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

NCT02363972 | Completed Results

• 1 other identifier: 01-0014-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

End Stage Renal Disease; AV Fistula; Fistula; End Stage Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Percent of Participants With Access Systems That Successfully Created an AVF

  90 days

• Percent of Access Sites With Clinical Patency at Discharge

  90 days

• Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days

  90 days

• Percent of Access Sites That Achieved or Maintained Maturation at 90 Days

  90 days

• Percent of Access Sites That Achieved Maturation Without Intervention

  90 days

Other Outcomes (3)

• Time to First AVF Cannulation

  90 days

• Catheter Utilization

  90 days

• Target Vessel Location

  90 days

Study Arms (1)

Ellipsys Vascular Access Catheter

EXPERIMENTAL

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

Interventions

Ellipsys Vascular Access Catheter DEVICE

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.

Ellipsys Vascular Access Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (5)

Southwest Vascular Center

Tempe, Arizona, 85281, United States

Location

BNMG San Diego Vascular Access Center

San Diego, California, 92115, United States

Location

Dallas Nephrology Associates

Plano, Texas, 75093, United States

Location

San Antonio Kidney Disease Center

San Antonio, Texas, 78016, United States

Location

Richmond Vascular Center

North Chesterfield, Virginia, 23236, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula; Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Gene Reu EVP and General Manager
• Organization: Avenu Medical

greu@avenumedical.com

9492762483

Study Officials

• Jeffrey Hull, MD

  Richmond Vascular Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 16, 2015
• Study Start: February 10, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 9, 2021
• Results First Posted: September 9, 2020

Record last verified: 2021-11

Locations

US (5)