Ellipsys Vascular Access System Post Market Surveillance (PS) Study

AV Fistula Clinical Trial

Official title:

Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04484220
• Other study ID #: PS200001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.

Description:

The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: September 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female = 18 years of age and = 80 years of age

2. Life expectancy of at least one year, in the investigator's opinion

3. Diagnosed with ESRD or chronic kidney disease on hemodialysis.

4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment

5. Adequate quality vein based on pre-operative assessment

1. Adjacent vein diameter of =2.0 mm at target anastomosis site

2. Confirmed clinically significant outflow

6. Adequate quality radial artery based on pre-operative assessment

a. Arterial lumen diameter of =2.0 mm at target anastomosis site

7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.

8. Radial artery-adjacent vein proximity =1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure

9. Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution

Imaging-based Inclusion Criteria:

10. Confirm radial artery-adjacent vein proximity =1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally

11. Confirm radial artery and adjacent vein diameter of =2.0 mm at target anastomosis site

Exclusion Criteria:

1. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:

1. Documented or suspected central venous stenosis (= 50%) or

2. Upper extremity arterial stenosis or

3. Vascular disease at the radial artery / adjacent vein site

2. Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy

3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment

4. Systolic pressures < 100 mg Hg at the time of screening

5. Suspected or confirmed skin disease at the skin entry site

6. Edema of the upper extremity on the ipsilateral side

7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day

8. Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment

9. Patients with acute or active infection

10. Scheduled kidney transplant within 6 months of enrollment

11. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)

12. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment

13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• AV Fistula
• Fistula
• Fistulas Arteriovenous
• Kidney Disease, End-Stage
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Disease, End Stage

Intervention

Device:
• Ellipsys Vascular Access System
The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	The Vascular Care Group	Hyannis	Massachusetts
United States	Azura Vascular Care, Jacksonville	Jacksonville	Florida
United States	Nephrology Kidney Disease Hypertension Center	Las Vegas	Nevada
United States	Yale University	New Haven	Connecticut
United States	Richmond Vascular Center	North Chesterfield	Virginia
United States	Coastal Vascular and Interventional, PLLC	Pensacola	Florida
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Nephrology Associates Access Center	Riverside	California
United States	San Antonio Kidney Disease Center	San Antonio	Texas
United States	STAR Vascular Access Center	San Antonio	Texas
United States	Staten Island Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Patency Through 12 months Post-AVF Creation	Freedom from access abandonment from time of access creation	12 months post-procedure
Primary	Early Occlusion Rate at 7 days	Percent of patients with total occlusion within 7 days of the AVF creation procedure	7 days post-procedure
Primary	Study Related Serious Adverse Event (SAE) Rate Through 12 months	Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.	12 months post-procedure
Secondary	Primary Patency Through 12 months Post-AVF Creation	Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months	12 months post-procedure
Secondary	Assisted Primary Patency Through 12 months Post-AVF Creation	Freedom from access thrombosis from time of access creation	12 months post-procedure
Secondary	Secondary Procedures Rate	Number of surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow per person-year.	12 months post-procedure
Secondary	Overall Patient Safety	A full characterization of adverse events during the study	12 months post-procedure