Catheter System Feasibility Clinical Trial

Renal Insufficiency, Chronic Clinical Trial

Official title:

Vessel-Select Catheter System Feasibility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816398
• Other study ID #: 01-0012-01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Percutaneous creation of an arteriovenous fistula
Use of catheter system for percutaneous creation of an arteriovenous fistula

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Endovascular	Hospital Universitario Dr. Jose E. Gonzalez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sufficient Patency for Clinical Access	Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.	6 weeks
Primary	Number of Patients Achieving Dialysis Access	Arteriovenous fistula is mature and patient has started dialysis using the fistula	6 weeks
Primary	Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis	Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis	3 months
Secondary	Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access	The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.	12 weeks