Ellipsys Vascular Access System Registry

Medtronic

Status: Completed

Conditions: End-stage Renal Disease

Treatments: Device: Ellipsys Vascular Access

Study type: Observational

Funder types: Industry

Identifiers

NCT03454113

1.0 ver 1.0 23 January 2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

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