Ellipsys Vascular Access System Registry

NCT03454113 | Completed FDA Device

• 1 other identifier: 1.0 ver 1.0 23 January 2017
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 5

Brief Summary

Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.

Conditions

End-stage Renal Disease

Keywords

dialysis autogenous arterio-venous fistula

Outcome Measures

Primary Outcomes (1)

• The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.

  Primary endpoint

  90 days

Secondary Outcomes (6)

• Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.

  12 months

• The length of time until a patient is able to undergo 2-needle cannulation for dialysis OR access vessel has a diameter ≥ 6 mm and a mean flow rate of ≥ 600 ml/min if the patient is not undergoing dialysis.

  12 months

• Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.

  12 months

• The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.

  12 months

• Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.

  12 months

Interventions

Ellipsys Vascular Access DEVICE

The Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with End-Stage Renal Disease or chronic kidney disease who provide written informed consent; who are currently require dialysis or it is anticipated will need dialysis within six months of enrollment; who meet all inclusion criteria and none of the exclusion criteria; and who are considered eligible for enrollment.

You may qualify if:

• 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 base on pre-operative assessment:
• Vein diameter of \> 2.0 mm at target anastomosis site
• Clinically significant outflow as determined by outflow mapping (ultrasound or v venography)
• Adequate quality artery base on pre-operative assessment:
• Arterial lumen diameter of \> 2.0 mm at target anastomosis site
• No significant calcification at the anastomosis site
• Radial artery at the wrist suitable for catheterization
• Radial artery-adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
• Patent palmar arch with adequate collateral perfusion as evidenced by Negative Allen's Test
• Able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant)

You may not qualify if:

• Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
• History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
• Evidence of clinically significant vascular disease at the radial artery/adjacent vein site on the ipsilateral side
• Systolic pressures \< 100 mg Hg at the time of treatment
• 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
• Known bleeding diathesis or coagulation disorder
• Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
• Patients with acute or active infection

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (5)

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum des Saarlandes

Saarbrücken, 66111, Germany

Location

Ammerland Klinik

Westerstede, 26655, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: July 1, 2017
• Primary Completion: April 17, 2019
• Study Completion: July 30, 2020
• Last Updated: February 8, 2021

Record last verified: 2020-11

Locations

DE (5)