Ellipsys Vascular Access System Registry

End-stage Renal Disease Clinical Trial

Official title:

Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454113
• Other study ID #: 1.0 ver 1.0 23 January 2017
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled 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 AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 30, 2020
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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:

1. Vein diameter of > 2.0 mm at target anastomosis site

2. Clinically significant outflow as determined by outflow mapping (ultrasound or v venography)

• Adequate quality artery base on pre-operative assessment:

1. Arterial lumen diameter of > 2.0 mm at target anastomosis site

2. No significant calcification at the anastomosis site

3. 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Ellipsys Vascular Access
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.

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg-Bad Krozingen	Bad Krozingen
Germany	Universitätsklinikum Düsseldorf	Dusseldorf
Germany	Universitätsklinikum Münster	Münster
Germany	Universitätsklinikum des Saarlandes	Saarbrücken
Germany	Ammerland Klinik	Westerstede

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.	Device Success Rate	12 months
Secondary	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.	Time to Functional Patency	12 months
Secondary	Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.	Dialysis Rate	12 months
Secondary	The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.	Secondary Procedure Rate	12 months
Secondary	Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.	Arterio-venous fistula patency	12 months
Secondary	Length of time from initial access creation to achieve Functional Patency or to time of abandonment of AVF.	Cumulative patency	12 months