Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

End Stage Renal Disease Clinical Trial

Official title:

Ellipsys Vascular Access Catheter System Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363972
• Other study ID #: 01-0014-01
• Status: Completed
• Phase: N/A
• Start date: February 10, 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2021
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients were eligible for enrollment into the study if they met the following criteria:

1. Patients = 18 years of age and = 80 years of age

2. Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)

3. Life expectancy of at least one year, per the investigator's opinion

4. Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment

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

6. 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

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

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

8. Adequate collateral arterial perfusion

1. Patent palmar arch

2. Negative Allen's Test for ulnar artery insufficiency

9. No clinical evidence of subclavian artery stenosis on the ipsilateral side.

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

11. Patient was able to provide written informed consent

12. Able to travel to enrolling institution for follow-up examinations

13. 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:

1. Documented or suspected central venous stenosis including upper extremity arterial stenosis (= 50%)

2. 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

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

4. Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side

5. Pre-existing vascular disease that could confound the study results

6. Systolic pressures < 100 mm Hg at the time of screening

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

8. Immunocompromised patients (e.g. HIV positive)

9. Edema of the upper extremity on the ipsilateral side

10. Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day

11. Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3

12. Current diagnosis of carcinoma (defined as in remission < 1 year)

13. Pregnant or currently breast feeding

14. Known bleeding diathesis or coagulation disorder

15. Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy

16. Patients with acute or active infection

17. Scheduled kidney transplant within 6 months of enrollment

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

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

20. Patient required creation of an arteriovenous fistula distal to the wrist

21. Patient required nerve block requiring immobilization of the arm

Related Conditions & MeSH terms

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

Intervention

Device:
• Ellipsys Vascular Access Catheter
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.

Locations

Country	Name	City	State
United States	Richmond Vascular Center	North Chesterfield	Virginia
United States	Dallas Nephrology Associates	Plano	Texas
United States	San Antonio Kidney Disease Center	San Antonio	Texas
United States	BNMG San Diego Vascular Access Center	San Diego	California
United States	Southwest Vascular Center	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to First AVF Cannulation	Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).	90 days
Other	Catheter Utilization	Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.	90 days
Other	Target Vessel Location	Anatomic location of matured target vessel	90 days
Primary	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
Primary	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	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
Secondary	Percent of Access Sites With Clinical Patency at Discharge	Percent of access sites that demonstrated physical exam patency through clinic discharge	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Transposition Rate	Percent of subjects who required one or more surgical transpositions performed to facilitate needle access	90 days