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Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Primary Purpose

Kidney Diseases, Arteriovenous Fistula

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EchoMark

About this trial

This is an interventional treatment trial for Kidney Diseases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
Subject is willing and capable of complying with all required follow-up visits
Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance
Subject has an estimated life expectancy > 18 months
Subject is ambulatory (cane or walker are acceptable)
Subjects presenting for upper arm autologous arteriovenous fistula creation
Vein diameter > 2.5 mm at the antecubital fossa via imaging
Artery diameter > 3 mm via imaging
Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.

Exclusion Criteria:

Subjects receiving a forearm fistula.
Subject has history of Steal Syndrome.
Subject who is immunocompromised or immunosuppressed.
Subject has had three previous failed AV fistulae for hemodialysis access
Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
Known or suspected active infection on the day of the index procedure.
Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula
Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
Subjects with active malignancy
Subjects with a history of poor compliance with the dialysis protocol
Subjects with a known or suspected allergy to any of the device materials
Subjects with an existing fistula or graft
Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

Sites / Locations

Trinity Research GroupRecruiting
SKI Vascular CenterRecruiting
Michgan Vascular CenterRecruiting
Surgical Specialist of CharlotteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EchoMark

Arm Description

All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint

Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including: Device or procedure-related death Device related infection Device related interventions Device related hospitalizations Fistula failure Fistula rupture Aneurysm

Primary Feasibility Endpoint

Rate of Technical Success defined as the successful implantation of the EchoMark implant and the ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.

Secondary Outcome Measures

Full Information

NCT ID

NCT04896476

First Posted

May 10, 2021

Last Updated

April 10, 2023

Sponsor

Sonavex, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04896476

Brief Title

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Official Title

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 21, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sonavex, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.

Detailed Description

This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases, Arteriovenous Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EchoMark

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

EchoMark

Intervention Description

The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.

Primary Outcome Measure Information:

Title

Primary Safety Endpoint

Description

Time Frame

30 Days

Title

Primary Feasibility Endpoint

Description

Time Frame

6 Months

Other Pre-specified Outcome Measures:

Title

Comparison of EchoSure and duplex measurements of flow

Description

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

Time Frame

6 Months

Title

Comparison of EchoSure and duplex measurements of diameter

Description

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

Time Frame

6 Months

Title

Comparison of EchoSure and duplex measurements of depth

Description

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

Time Frame

6 Months

Title

Time to radiographic maturation

Description

defined as the number of days from baseline procedure to date of radiographic maturation (date of ultrasound imaging, as adjudicated by the CEC). Radiographic maturation is defined as a fistula with volume flow of 500mL/min and 5mm diameter.

Time Frame

12 Months

Title

Time to clinical maturation

Description

defined as the number of days from baseline procedure to date of clinical maturation. Clinical maturation is defined as 75% of dialysis sessions with successful 2 needle cannulation. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

Time Frame

12 Months

Title

Radiographic maturation success rate

Description

defined as the percentage of subjects that achieve radiographic maturation (as determined by the physician and adjudicated by the CEC) by end of study. Radiographic maturation is defined as a fistula with 500mL/min and 5mm diameter.

Time Frame

12 Months

Title

Clinical maturation success rate

Description

defined as the percentage of subjects that achieve clinical maturation by end of study. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

Time Frame

12 Months

Title

6-month patency rate

Description

defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).

Time Frame

6 Months

Title

12-month patency rate

Description

Time Frame

12 Months

Title

Occurrence of events occurring within 30 days of implantation that require reinterventions (open or endovascular), hospitalizations, or prolongation of existing hospitalization.

Time Frame

30 Days

Title

Occurrence of reported reduction of blood flow that prevents the ability to cannulate or requires further assessment and/or intervention from baseline procedure to 12 months.

Time Frame

12 Months

Title

Occurrence of the reported inability to cannulate fistula beginning once the fistula is deemed radiographically and clinically mature to 12 months.

Time Frame

12 Months

Title

Occurrence of the development of steal syndrome from baseline to 12 months.

Time Frame

12 Months

Title

Occurrence of bleeding requiring surgical intervention (including PRBC transfusion) from baseline to 12 months.

Time Frame

12 Months

Title

Occurrence of infiltration requiring procedural intervention from baseline to 12 months.

Time Frame

12 Months

Title

Occurrence of hematoma requiring procedural intervention from baseline to 12 months.

Time Frame

12 Months

Title

Occurrence of the inability to use the EchoSure component of the system from baseline to 4 months

Description

Due to: Migration of the EchoMark device Early resorption of the EchoMark device as defined as breakdown of the EchoMark shape prior to 4 months from index procedure.

Time Frame

4 Months

Title

Occurrence of pain related to the study devices from baseline to 12 months

Time Frame

12 Months

Title

Occurrence of infection (not limited to infection requiring implant explanation) from baseline to 12 months

Time Frame

12 Months

Title

Occurrence of infection confirmed by either implant explanation or purulent fluid on pathologic assessment during incision and drainage beginning at baseline to 12 months

Time Frame

12 Months

Title

Composite of new major device related adverse events (MAEs) at 12 months post EchoMark LP implantation, as adjudicated by the Clinical Events Committee (CEC).

Description

The proportion of subjects with device success and free from device- and/or procedure related SAEs (per CEC adjudication) at 12 months. The summaries for each individual safety data point will also be provided, including: Device or procedure-related death Device related infection Device related interventions Device related hospitalizations Fistula failure Fistula rupture Aneurysm

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures Subject is willing and capable of complying with all required follow-up visits Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance Subject has an estimated life expectancy > 18 months Subject is ambulatory (cane or walker are acceptable) Subjects presenting for upper arm autologous arteriovenous fistula creation Vein diameter > 2.5 mm at the antecubital fossa via imaging Artery diameter > 3 mm via imaging Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable. Exclusion Criteria: Subjects receiving a forearm fistula. Subject has history of Steal Syndrome. Subject who is immunocompromised or immunosuppressed. Subject has had three previous failed AV fistulae for hemodialysis access Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation. Known or suspected active infection on the day of the index procedure. Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access Subjects with active malignancy Subjects with a history of poor compliance with the dialysis protocol Subjects with a known or suspected allergy to any of the device materials Subjects with an existing fistula or graft Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katy Feeny

Phone

443-862-2024

kfeeny@sonavex.com

Facility Information:

Facility Name

Trinity Research Group

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36301

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

E Ivey

Facility Name

SKI Vascular Center

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M McNally

Facility Name

Michgan Vascular Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48507

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

B Lewis

Facility Name

Surgical Specialist of Charlotte

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

D Taylor

12. IPD Sharing Statement

Learn more about this trial

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

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