Chronic Kidney Diseases
Conditions
Brief summary
Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.
Detailed description
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects will be followed for up to 12 months post index procedure based on Investigator's discretion.
Interventions
DEVICEeverlinQ endoAVF System
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Eligible for a native arteriovenous fistula. 2. Adult (age \>18 years old). 3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients). 4. Target vein diameter(s) ≥ 2.0 mm or large enough to accommodate device diameter. 5. Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter. 6. Estimated life expectancy \> 1 year. 7. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure
Exclusion criteria
1. Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation. 2. Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by everlinQ System as deemed by the interventionalists' clinical judgment. 3. Prior surgically created access in the planned treatment location. 4. Functioning surgical access in the planned treatment arm. 5. Pregnant women. 6. New York Heart Association (NYHA) class III or IV heart failure. 7. Hypercoagulable state. 8. Known bleeding diathesis. 9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition. 10. Documented history of drug abuse including intravenous drugs within six months of AVF creation. 11. Planned concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment. 12. Currently being treated with another investigational device or drug. 13. Known allergy to contrast dye which cannot be adequately pre-medicated. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16 14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. 15. Patients who do not have an ulnar or radial artery. 16. At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula. 17. Evidence of active infections on the day of the index procedure. 18. Written informed consent not obtained.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Protocol-Defined endoAVF Maturation | Through 6 months post-index procedure | Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles. |
| Number of Participants With Device-Related SAEs | 3 months following AVF creation | The safety Endpoint is protocol-defined as Device-Related SAE at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency at 6 Months Post-index Procedure | 6 months post-index procedure | Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment. |
| Number of Participants Per Catheter Exposure Type | 1-7 days, 30 days, 3, and 6 months post-index procedure | Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure. |
| Number of Days to Fistula Maturation | Days from Index Procedure | Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation). |
| Number of Endo-AVF-related Re-interventions | At 6 months follow-up | The re-intervention rate for endo-AVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post-index procedure. |
| Number of Participants With Technical Success | 1-7 days following index-procedure | Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram. |
| Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure | 6 months post-index procedure | Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment. |
Participant flow
Recruitment details
First subject enrolled July 27, 2015 and last subject enrolled November 8, 2016. Last subject follow-up was June 19, 2017.
Participants by arm
| Arm | Count |
|---|---|
| endoAVF everlinQ endoAVF System | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | endoAVF |
|---|---|
| Access Arm Left | 25 Participants |
| Access Arm Right | 7 Participants |
| Access Artery Brachial | 9 Participants |
| Access Artery Radial | 19 Participants |
| Access Artery Ulnar | 4 Participants |
| Access Vein Brachial | 13 Participants |
| Access Vein Radial | 17 Participants |
| Access Vein Ulnar | 2 Participants |
| Age, Customized Age of Participants | 50.9 Years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fistula Type Radial-Radial | 20 Participants |
| Fistula Type Ulnar-Ulnar | 12 Participants |
| Region of Enrollment Paraguay | 32 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 32 |
| other Total, other adverse events | 7 / 32 |
| serious Total, serious adverse events | 2 / 32 |
Outcome results
Primary
Number of Participants With Device-Related SAEs
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Time frame: 3 months following AVF creation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants With Device-Related SAEs | 0 Participants |
Primary
Number of Participants With Protocol-Defined endoAVF Maturation
Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.
Time frame: Through 6 months post-index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants With Protocol-Defined endoAVF Maturation | 29 Participants |
Secondary
Number of Days to Fistula Maturation
Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).
Time frame: Days from Index Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| endoAVF | Number of Days to Fistula Maturation | 9.2 Days from Index Procedure | Standard Deviation 19.1 |
Secondary
Number of Endo-AVF-related Re-interventions
The re-intervention rate for endo-AVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post-index procedure.
Time frame: At 6 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Endo-AVF-related Re-interventions | 2 Participants |
Secondary
Number of Participants Per Catheter Exposure Type
Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.
Time frame: 1-7 days, 30 days, 3, and 6 months post-index procedure
Population: Number of participants (n) for each follow-up period varies from total participants in the study (N=32) according to the number of participants that attend follow-up and/or had data relevant to the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC only at 1-7 days post index procedure | 31 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | EndoAVF only at 1-7 days post index procedure | 0 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC & endoAVF at 1-7 days post index procedure | 0 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | No dialysis at 1-7 days post-index procedure | 1 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC only at 30 days post-index procedure | 26 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | EndoAVF only at 30 days post-index procedure | 1 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC & endoAVF at 30 days post-index procedure | 0 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | No dialysis at 30 days post-index procedure | 1 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC only at 3 months post-index | 5 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | EndoAVF only 3 months post-index | 10 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC + endoAVF at 3 months post-index | 0 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | No dialysis at 3 months post-index | 1 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC only at 6 months post-index | 7 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | EndoAVF only 6 months post-index | 19 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | CVC + endoAVF at 6 months post-index | 0 Participants |
| endoAVF | Number of Participants Per Catheter Exposure Type | No dialysis at 6 months post-index | 0 Participants |
Secondary
Number of Participants With Technical Success
Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.
Time frame: 1-7 days following index-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants With Technical Success | 30 Participants |
Secondary
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.
Time frame: 6 months post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure | 86.8 Percentage of participants |
Comparison: This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis.
Secondary
Primary Patency at 6 Months Post-index Procedure
Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.
Time frame: 6 months post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Primary Patency at 6 Months Post-index Procedure | 83.3 Percentage of participants |
Comparison: This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis.