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everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
NA trial testing everlinQ endoAVF System in Chronic Kidney Diseases in 24 participants. Completed in 12 December 2018.
| Lead sponsor | C. R. Bard |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 16 October 2017 |
| Primary completion | 12 December 2018 |
| Estimated completion | 12 December 2018 |
| Sites | 1 location across Paraguay |
C. R. Bard — full company profile →
18 and older, any sex, with Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 19 |
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 4 |
Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 70.8 |
Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 19 |
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 20 |
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 20 |
The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 1.2 | ± 0.3 |
A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 0 |
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 11 |
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 13 |
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 13 |
Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 70.8 |
Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 70.8 |
The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 90.9 | 50.8 – 98.7 |
The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 3 |
Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.
| Group | Value | 95% CI |
|---|---|---|
| endoAVF | 70.8 |
Time frame: Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | endoAVF |
|---|---|---|
| Thrombosis | Vascular disorders | — |
| Pseudoanurysm | Vascular disorders | — |
| Infection | Infections and infestations | — |
| Reaction | System | endoAVF |
|---|---|---|
| Pseudo-aneurysm | Vascular disorders | — |
| Thrombosis | Vascular disorders | — |
| Occlusion | Vascular disorders | — |
| Swelling | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Thrombosis, Pseudoanurysm, Infection.
Data from ClinicalTrials.gov NCT03708562 adverse events section.
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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