Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Not Applicable

Completed

• Conditions: Fistula; End Stage Renal Disease; End Stage Kidney Disease; AV Fistula
• Interventions: Device: Ellipsys Vascular Access Catheter

• Registration Number: NCT02363972
• Lead Sponsor: Medtronic Endovascular

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-06
• Study Start: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-16
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-21
• Results First Posted: 2020-09-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ellipsys Vascular Access Catheter	Ellipsys Vascular Access Catheter	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.

Primary Outcome Measures

Name	Time	Method
Maturation Success Rate at 90 Days	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.
Number of Participants With Device-related Serious Adverse Events	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Percent of Access Sites That Achieved or Maintained Maturation at 90 Days	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.
Percent of Access Sites That Were Patent Following Intervention	90 days	Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency
Intervention Rate	90 days	Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site
Percent of Participants With Access Systems That Successfully Created an AVF	90 days	Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment
Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days	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
Percent of Access Sites That Achieved Maturation Without Intervention	90 days	Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation
Percent of Access Sites With Clinical Patency at Discharge	90 days	Percent of access sites that demonstrated physical exam patency through clinic discharge
Percent of Access Sites That Achieved Patency Without Intervention	90 days	Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site
Transposition Rate	90 days	Percent of subjects who required one or more surgical transpositions performed to facilitate needle access

Trial Locations

Locations (5)

Richmond Vascular Center; 🇺🇸 North Chesterfield, Virginia, United States

Southwest Vascular Center; 🇺🇸 Tempe, Arizona, United States

San Antonio Kidney Disease Center; 🇺🇸 San Antonio, Texas, United States

BNMG San Diego Vascular Access Center; 🇺🇸 San Diego, California, United States

Dallas Nephrology Associates; 🇺🇸 Plano, Texas, United States