Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

NCT ID: NCT02363972

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-10
• Study Completion Date: 2016-06-30

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.

Conditions

End Stage Renal Disease; AV Fistula; Fistula; End Stage Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ellipsys Vascular Access Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Hull, MD

Role: PRINCIPAL_INVESTIGATOR

Richmond Vascular Center

Locations

Southwest Vascular Center

Tempe, Arizona, United States

BNMG San Diego Vascular Access Center

San Diego, California, United States

Dallas Nephrology Associates

Plano, Texas, United States

San Antonio Kidney Disease Center

San Antonio, Texas, United States

Richmond Vascular Center

North Chesterfield, Virginia, United States

Countries

United States

Other Identifiers

01-0014-01

Identifier Type: -

Identifier Source: org_study_id