Trial Outcomes & Findings for Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD (NCT NCT02363972)

NCT ID: NCT02363972

Last Updated: 2021-11-09

Results Overview

Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2021-11-09

Participant Flow

Participant milestones

Measure	Ellipsys Vascular Access Catheter ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Overall Study STARTED	103
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Baseline characteristics by cohort

Measure	Ellipsys Vascular Access Catheter n=103 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Age, Continuous	56.6 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	21 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=103 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Maturation Success Rate at 90 Days

92 Participants

PRIMARY outcome

Timeframe: 90 days

The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=103 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Number of Participants With Device-related Serious Adverse Events

0 Participants

SECONDARY outcome

Timeframe: 90 days

Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=103 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Participants With Access Systems That Successfully Created an AVF

102 Participants

SECONDARY outcome

Timeframe: 90 days

Percent of access sites that demonstrated physical exam patency through clinic discharge

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites With Clinical Patency at Discharge

98 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (65) is a subset of of the overall number of participants analyzed (103) due to not all participants being on dialysis an requiring 2 needle cannulation by the 90 day outcome measure time frame

Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=65 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days

29 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites That Achieved or Maintained Maturation at 90 Days

85 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites That Achieved Maturation Without Intervention

1 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites That Were Patent Following Intervention

89 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Percent of Access Sites That Achieved Patency Without Intervention

1 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Intervention Rate

98 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure

Percent of subjects who required one or more surgical transpositions performed to facilitate needle access

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=102 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Transposition Rate

19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: The analysis population analyzed (33) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring cannulation by the 90 day outcome timeframe

Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=33 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Time to First AVF Cannulation

67.8 Days Standard Deviation 15.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: The analysis population analyzed (32) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring a catheter utilization by the 90 day outcome timeframe

Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.

Outcome measures

Measure

Ellipsys Vascular Access Catheter n=32 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

Catheter Utilization

83.1 days Standard Deviation 17.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: The analysis population analyzed (90) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not achieving an identifiable target vein by the 90 day outcome timeframe

Anatomic location of matured target vessel

Outcome measures

Measure	Ellipsys Vascular Access Catheter n=90 Participants ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Target Vessel Location Cephalic vein	68 Participants
Target Vessel Location Basilic vein	20 Participants
Target Vessel Location Brachial vein 1	1 Participants
Target Vessel Location Brachial vein 2	1 Participants

Adverse Events

Ellipsys Vascular Access Catheter

Serious events: 18 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ellipsys Vascular Access Catheter n=103 participants at risk ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Cardiac disorders Cardiac serious adverse events	3.9% 4/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Endocrine disorders Endocrine, metabolic nutritional serious adverse events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders Gastrointestinal serious adverse events	1.9% 2/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders Musculoskeletal serious adverse events	1.9% 2/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Nervous system disorders Nervous system serious adverse events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders Respiratory serious adverse events	1.9% 2/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Skin and subcutaneous serious adverse events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Vascular disorders Vascular, blood and lymphatic serious adverse events	3.9% 4/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Social circumstances Uncoded	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Other adverse events

Measure	Ellipsys Vascular Access Catheter n=103 participants at risk ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Ear and labyrinth disorders Eye, ear nonserious events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Immune system disorders Immune, infection nonserious events	2.9% 3/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders musculoskeletal nonserious adverse events	2.9% 3/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Skin and subcutaneous tissue disorders Skin nonserious adverse events	1.9% 2/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Surgical and medical procedures Surgical procedure nonserious adverse events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Vascular disorders Vascular, blood nonserious adverse events	16.5% 17/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Investigations Drug effect nonserious adverse events	0.97% 1/103 • 90 days Serious Adverse Events and Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Gene Reu EVP and General Manager

Avenu Medical

Phone: 9492762483

Email: greu@avenumedical.com

Results disclosure agreements

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