Catheter System Feasibility Clinical Trial

NCT ID: NCT02816398

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Renal Insufficiency, Chronic

Study Design

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

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Percutaneous creation of an arteriovenous fistula

Intervention Type: DEVICE

Use of catheter system for percutaneous creation of an arteriovenous fistula

Interventions

Percutaneous creation of an arteriovenous fistula

Use of catheter system for percutaneous creation of an arteriovenous fistula

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: collaborator

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

01-0012-01

Identifier Type: -

Identifier Source: org_study_id