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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.
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoAVF | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everlinQ endoAVF System | Device | The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedural Success | Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure. | At time of procedure |
| Adverse Event Rate | 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). | 3 months following endoAVF creation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Primary Patency at 6 Months Post Index Procedure | 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. | 6 months post index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Ebner | Sanatorio Italiano, Paraguay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Italiano | Asunción | Paraguay |
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The EverlinQ Endovascular Access Systems Enhancements (EASE-2) study began enrollment on October 5th 2017 and the last patient was enrolled on May 23rd 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | endoAVF | everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | endoAVF | everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. RF energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Procedural Success | Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure. | Posted | Count of Participants | Participants | At time of procedure |
|
Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.
Significant Events were classified by the independent Medical Monitor and included device or procedure-related adverse events that either a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit, irrespective of whether they met the criteria for an SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | endoAVF | everlinQ endoAVF System: The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pseudo-aneurysm | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Rothwell | Becton Dickinson (BPV) | 480-350-6037 | courtney.rothwell@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2017 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure | 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. | 1, 3, and 6 months post index procedure |
| Time to Cannulation (Months) | The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF. | Months from index procedure to cannulation |
| Number of Participants With Cannulation Success at Defined Follow-up Intervals | 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). | 0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure |
| Percentage of Participants With Assisted Primary Patency at 6 Months | Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion. | 6 months post index procedure |
| Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure | 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. | 6 months post index procedure |
| Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure | 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. | 6 months post index procedure |
| Number of Participants With EndoAVF Related Reintervention | 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. | At 6 months follow-up |
| Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure | 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. | 6 months post index procedure |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Access Artery | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Adverse Event Rate | 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). | Posted | Count of Participants | Participants | 3 months following endoAVF creation |
|
|
|
| Secondary | Percentage of Participants With Primary Patency at 6 Months Post Index Procedure | 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. | Posted | Number | Percentage of participants | 6 months post index procedure |
|
|
|
| Secondary | Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure | 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. | Posted | Count of Participants | Participants | 1, 3, and 6 months post index procedure |
|
|
|
| Secondary | Time to Cannulation (Months) | The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF. | Analysis population is lower than total subject number due to subject withdrawals before this endpoint could be analyzed. | Posted | Mean | Standard Deviation | Months | Months from index procedure to cannulation |
|
|
|
| Secondary | Number of Participants With Cannulation Success at Defined Follow-up Intervals | 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). | Overall number of participants analyzed (n), and participants analyzed for each follow-up period varies from total participants in the study (N=24) according to the number of participants that attend follow-up and/or had data relevant to the analysis. | Posted | Count of Participants | Participants | 0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure |
|
|
|
| Secondary | Percentage of Participants With Assisted Primary Patency at 6 Months | Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion. | Posted | Number | Percentage of Participants | 6 months post index procedure |
|
|
|
| Secondary | Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure | 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. | Posted | Number | Percentage of participants | 6 months post index procedure |
|
|
|
| Secondary | Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months post index procedure |
|
|
|
| Secondary | Number of Participants With EndoAVF Related Reintervention | 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. | Posted | Count of Participants | Participants | At 6 months follow-up |
|
|
|
| Secondary | Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure | 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. | Posted | Number | Percentage of participants | 6 months post index procedure |
|
|
|
| 2 |
| 24 |
| 4 |
| 24 |
| 6 |
| 24 |
| Pseudoanurysm | Vascular disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Occlusion | Vascular disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
|
| 46-135 days post index procedure |
|
|
| 136-210 days post index procedure |
|
|