Arteriovenous Fistula, Arteriovenous Graft
Conditions
Brief summary
This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.
Detailed description
This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.
Interventions
DEVICEEchoMark/EchoSure
Each subject will have an EchoMark implanted at the time of arteriovenous fistula creation, and undergo EchoSure and duplex imaging follow-up.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Sonavex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan * Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation * Women of childbearing potential have a negative pregnancy test
Exclusion criteria
* Age \<18 years old * Patient unable to sign informed consent * Patient participating in another investigational device or pharmacological study * Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance: Data Collection | 24 weeks | Data collection to verify accuracy |
| Performance Endpoint | 24 Weeks | Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail. |
| Safety Endpoint | 24 Weeks | Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EchoMark/EchoSure Stage 1 EchoMark implantation at the time of fistula creation with scheduled follow up for EchoSure imaging of the fistula maturation process. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | EchoMark/EchoSure Stage 1 |
|---|---|
| Age, Continuous | 68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 17 |
| other Total, other adverse events | 5 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Performance: Data Collection
Data collection to verify accuracy
Time frame: 24 weeks
Population: Data was not collected.
Primary
Performance Endpoint
Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.
Time frame: 24 Weeks
Population: Data was not collected.
Primary
Safety Endpoint
Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.
Time frame: 24 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark/EchoSure Stage 1 | Safety Endpoint | 16 Participants |