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Completed

NCT Number: NCT02816398

Catheter System Feasibility Clinical Trial

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous creation of an arteriovenous fistula

Device

Use of catheter system for percutaneous creation of an arteriovenous fistula

Primary outcomes

  1. Number of Participants With Sufficient Patency for Clinical Access

    Time frame: 6 weeks

    Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.

  2. Number of Patients Achieving Dialysis Access

    Time frame: 6 weeks

    Arteriovenous fistula is mature and patient has started dialysis using the fistula

  3. Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis

    Time frame: 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 outcomes

  1. Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access

    Time frame: 12 weeks

    The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

Registry information

Official study title

Vessel-Select Catheter System Feasibility Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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