Renal Insufficiency, Chronic
Conditions
Brief summary
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
Interventions
DEVICEPercutaneous creation of an arteriovenous fistula
Use of catheter system for percutaneous creation of an arteriovenous fistula
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment * Patients diagnosed with chronic kidney disease classification stage IV or V * Adequate quality vein \>= 2 mm with confirmed clinically significant outflow based on pre-operative assessment * Adequate quality radial artery \>= 2 mm based on pre-operative assessment * Adequate collateral arterial perfusion * Radial artery-adjacent vein proximity \< = 1.5 mm * Able to provide informed consent * Able to travel to institution for follow up examination * Able to intraoperatively place an .014 guidewire in artery
Exclusion criteria
* Suspected skin disease * Immunocompromised patients (e.g. HIV positive) * Edema of extremities * Current diagnosis of carcinoma * Pregnancy or currently breast feeding * Diagnosed hypercoaguable state * Active infection * Evidence of vascular disease at target site * Pre-existing vascular disease that could confound study results * Vessel tortuosity or spasm preventing placement of .014 guidewire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sufficient Patency for Clinical Access | 6 weeks | Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate. |
| Number of Patients Achieving Dialysis Access | 6 weeks | Arteriovenous fistula is mature and patient has started dialysis using the fistula |
| Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | 3 months | Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | 12 weeks | The number of patients requiring additional interventions to achieve maturation and initiation of dialysis. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 45.5 Years STANDARD_DEVIATION 13.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Mexico | 26 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 9 / 23 |
Outcome results
Primary
Number of Participants With Sufficient Patency for Clinical Access
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Time frame: 6 weeks
Population: Patency at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Sufficient Patency for Clinical Access | 20 Participants |
Primary
Number of Patients Achieving Dialysis Access
Arteriovenous fistula is mature and patient has started dialysis using the fistula
Time frame: 6 weeks
Population: Patients on dialysis at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Patients Achieving Dialysis Access | 1 Participants |
Primary
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
Time frame: 3 months
Population: Patients on dialysis or achieved suitable access flow rate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | 20 Participants |
Secondary
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
Time frame: 12 weeks
Population: Number of additional interventions to achieve suitability for dialysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | 23 Participants |