Catheter System Feasibility Clinical Trial

Medtronic

Status: Completed

Conditions: Renal Insufficiency, Chronic

Treatments: Device: Percutaneous creation of an arteriovenous fistula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02816398

01-0012-01

Details and patient eligibility

About

Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
• Patients diagnosed with chronic kidney disease classification stage IV or V
• Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
• Adequate quality radial artery >= 2 mm based on pre-operative assessment
• Adequate collateral arterial perfusion
• Radial artery-adjacent vein proximity < = 1.5 mm
• Able to provide informed consent
• Able to travel to institution for follow up examination
• Able to intraoperatively place an .014" guidewire in artery

Exclusion criteria

• Suspected skin disease
• Immunocompromised patients (e.g. HIV positive)
• Edema of extremities
• Current diagnosis of carcinoma
• Pregnancy or currently breast feeding
• Diagnosed hypercoaguable state
• Active infection
• Evidence of vascular disease at target site
• Pre-existing vascular disease that could confound study results
• Vessel tortuosity or spasm preventing placement of .014" guidewire

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Treatment

Experimental group

Description:

Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula

Treatment:

Device: Percutaneous creation of an arteriovenous fistula