End-stage Kidney Disease, End-stage Renal Disease
Conditions
Keywords
End-stage renal disease, ESRD, AVF, Fistulas
Brief summary
The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.
Detailed description
The investigation is designed as a multi-center, prospective, single-arm, clinical study of the Optiflow performance and safety in a maximum of 180 subjects which includes one (1) roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures. Results will be compared to a pre-established performance goal. Up to fifteen (15) investigational sites will participate in the investigational study. The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound. The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
Interventions
DEVICEOptiflow
The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access.
Sponsors
Bioconnect Systems, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive age). * Life expectancy of at least one year, per the investigator's opinion. * Diagnosed with ESRD or chronic kidney disease requiring dialysis. * Planned upper extremity autogenous arteriovenous fistula. * Planned anastomosis is an end of vein to side of artery configuration. * AVF target artery and vein inner diameters are greater or equal to 3.0 mm and less than or equal to 7.0 mm as determined by pre-operative ultrasound and confirmed intra-operatively. * Patient is available and willing to return for follow-up visits during the duration of the study. * Patient is able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen not including warfarin (see
Exclusion criteria
). * Patient, or their legal representative, is willing and able to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Maturation | 90 days | The primary performance endpoint is the maturation percentage rate at 90 days. Maturation is defined as an access site intended for dialysis needle cannulation which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal to 500 mL/min as measured via duplex ultrasound. |
| Serious Adverse Events Associated with Arteriovenous Fistula Creation | 90 days | The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days. All patients will be followed for safety for the duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 day | Technical success rate: An access site that demonstrates physical exam patency through hospital discharge. |
| Assisted Maturation | 90 days | Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. |
| Unassisted Maturation | 90 days | Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation. |
| Assisted Patency | 90 days | Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency. |
| Unassisted Patency | 90 days | Unassisted patency rate: An access site that maintains patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site. |
| Intervention Rate | 90 days | Intervention rate: The number of occurrences that a subject's access site is surgically or endovascularly operated on to maintain or reestablish blood flow in the access site. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound flow | 90 days | Flow rate of blood through outflow vein |
| Time To Access Site Abandonment | Up to 90 days | Elapsed time to abandonment of the access site. |
| Access Site Related Adverse Events | 90 days | The number of access related adverse events per subject |
| Number of Access Site Related Hospitalizations | 90 days | The number of access site related hospitalizations per subject. |
| Catheter Utilization | 90 days | Total number of days a catheter was used before access site maturation per subject. |
| Total Adverse Events | 90 days | Total number of adverse events |
| Time to first cannulation | Up to 90 days | Elapsed time to first use of access site. |
Countries
United States
Outcome results
None listed