Catheter System Feasibility Clinical Trial

Not Applicable

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Device: Percutaneous creation of an arteriovenous fistula

• Registration Number: NCT02816398
• Lead Sponsor: Medtronic Endovascular

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Results First Submitted: 2018-06-25
• Results First Submitted QC: 2020-08-11
• Results First Posted: 2020-08-12
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Percutaneous creation of an arteriovenous fistula	Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sufficient Patency for Clinical Access	6 weeks	Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Number of Patients Achieving Dialysis Access	6 weeks	Arteriovenous fistula is mature and patient has started dialysis using the fistula
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis	3 months	Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis

Secondary Outcome Measures

Name	Time	Method
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access	12 weeks	The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.