Trial Outcomes & Findings for Catheter System Feasibility Clinical Trial (NCT NCT02816398)

NCT ID: NCT02816398

Last Updated: 2021-02-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-02-05

Participant Flow

Participant milestones

Measure	Treatment Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Overall Study STARTED	26
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Treatment Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Overall Study Death	5
Overall Study Lack of Efficacy	8
Overall Study Lost to Follow-up	1

Baseline Characteristics

Catheter System Feasibility Clinical Trial

Baseline characteristics by cohort

Measure	Treatment n=26 Participants Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	45.5 Years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	26 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Patency at 6 weeks

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

Outcome measures

Measure	Treatment n=26 Participants Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Number of Participants With Sufficient Patency for Clinical Access	20 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Patients on dialysis at 6 weeks

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

Outcome measures

Measure	Treatment n=26 Participants Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Number of Patients Achieving Dialysis Access	1 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Patients on dialysis or achieved suitable access flow rate

Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis

Outcome measures

Measure	Treatment n=26 Participants Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis	20 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of additional interventions to achieve suitability for dialysis

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

Outcome measures

Measure	Treatment n=26 Participants Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access	23 Participants

Adverse Events

Treatment

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=23 participants at risk Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula
General disorders Death	21.7% 5/23 • Number of events 5 • Adverse event data was collected over a period of 6 months from index procedure through arteriovenous fistula maturation
Blood and lymphatic system disorders Hematoma	4.3% 1/23 • Number of events 1 • Adverse event data was collected over a period of 6 months from index procedure through arteriovenous fistula maturation
Vascular disorders Acute thrombosis	13.0% 3/23 • Number of events 3 • Adverse event data was collected over a period of 6 months from index procedure through arteriovenous fistula maturation

Other adverse events

Adverse event data not reported

Additional Information

Gene Reu

Avenu Medical - Sponsor

Phone: 949 276 2483

Email: greu@avenumedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place