Chronic Kidney Disease
Conditions
Brief summary
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age \>18 years old) * Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation * Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram * Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram * Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
Exclusion criteria
* Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation * Absence of perforator feeding the target cannulation vein(s) via Venogram * Occlusion or stenosis \>50% of target cannulation cephalic or basilic vein * Significantly compromised (≥50% stenosis) flow in the treatment arm * Documented ejection fraction (EF) ≤35% in the last 6 months * Pregnant women * New York Heart Association (NYHA) class III or IV heart failure * Hypercoagulable state * Known bleeding diathesis * Documented history of drug abuse including intravenous drugs within six months of AVF creation * Planned concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment * Known allergy to contrast dye which cannot be adequately pre-medicated * Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated * Evidence of active infections on the day of the index procedure * Estimated life expectancy \< 1 year * Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up * Patient with a target cannulation vein that is \> 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula * Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure | endoAVF creation through 6 months | Primary patency was defined in this study as The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure | endoAVF creation through 6 Months | Secondary Patency in this study was defined as The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access. |
| Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure | endoAVF creation through 6 Months | Functional Patency in this study was defined as The interval of time from the first 2-needle dialysis utilizing the access until access abandonment. |
| Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF | endoAVF creation to cannulation | The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points. |
| Number of Participants With Procedural Success at the Index Procedure | endoAVF creation | The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation. |
| Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | endoAVF creation | The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit. This outcome measure is assessed at the time of the endoAVF creation. |
| Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure | endoAVF creation through 6 Months | Assisted Primary Patency was defined in this study as The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion. |
| Participants in Which endoAVF Maturation Was Achieved | endoAVF creation through 6 months | Total time from successful endoAVF creation to one of the following: * Successful hemodialysis using 2 needle cannulation OR * Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound. Note: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint. |
| Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points | endoAVF creation through 6 Months | Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points. |
| Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure | endoAVF creation through 6 Months | AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System |
| Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure | endoAVF creation through 6 Months | AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure |
| Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | endoAVF creation through 6 Months | The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit. |
Countries
Canada, Germany, United Kingdom
Participant flow
Recruitment details
The everlinQ endoAVF Post Market Study began enrollment on September 20th 2016 and the last patient was enrolled on January 17th 2019.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | endoAVF |
|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 16.2 |
| Body Mass Index (BMI) | 28.4 kg/m^2 STANDARD_DEVIATION 7.6 |
| EndoAVF Device 4 French | 64 Participants |
| EndoAVF Device 6 French | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 70 Participants |
| Region of Enrollment Canada | 14 participants |
| Region of Enrollment Germany | 26 participants |
| Region of Enrollment Netherlands | 1 participants |
| Region of Enrollment United Kingdom | 59 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 100 |
| other Total, other adverse events | 7 / 100 |
| serious Total, serious adverse events | 24 / 100 |
Outcome results
Primary
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Primary patency was defined in this study as The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency.
Time frame: endoAVF creation through 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure | 71 percentage of participants |
Post Hoc
Dialysis Status
This outcome measure references the participant's dialysis status throughout the study. Participants who began dialysis during the study and participants who were not on dialysis through the end of the study were not on dialysis at baseline.
Time frame: endoAVF creation through 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| endoAVF | Dialysis Status | On Dialysis at Enrollment | 47 participants |
| endoAVF | Dialysis Status | Began Dialysis During Study | 24 participants |
| endoAVF | Dialysis Status | Not on Dialysis Through End of Study | 29 participants |
Other Pre-specified
Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF
The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.
Time frame: endoAVF creation to cannulation
Population: Only participants remaining in the study that were on dialysis can be counted for this endpoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| endoAVF | Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF | 84 days |
Other Pre-specified
Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure
AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure | 3 Participants |
Other Pre-specified
Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure
AE that: * led to death, * led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, * led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure | 11 Participants |
Other Pre-specified
Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points
Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points | 22 Participants |
| At 3 Months | Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points | 23 Participants |
Other Pre-specified
Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)
The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit.
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Total Maturation and Maintenance Interventions | 26 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Subjects with ≥1 Reintervention | 24 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Total Maturation Interventions | 18 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Superficialization (Maturation) | 10 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Coiling (Maturation) | 8 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Total Maintenance Interventions | 8 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | PTA (Maintenance) | 6 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Stent Placement (Maintenance) | 1 Participants |
| endoAVF | Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions) | Thrombolysis (Maintenance) | 1 Participants |
Other Pre-specified
Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)
The endoAVF-related interventions include: * Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site. * Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins. * Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula. * Any intervention to address any complications or adverse events of the access circuit. This outcome measure is assessed at the time of the endoAVF creation.
Time frame: endoAVF creation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Therapeutic Coil Embolization | 73 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Balloon Angioplasty | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Stent | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Thrombectomy | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Thrombolytic Therapy | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Transposition | 2 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Creation of Surgical AVF/Graft | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Other | 0 Participants |
| endoAVF | Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures) | Participants with ≥1 Adjunctive Procedures | 74 Participants |
Other Pre-specified
Number of Participants With Procedural Success at the Index Procedure
The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.
Time frame: endoAVF creation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Number of Participants With Procedural Success at the Index Procedure | 94 Participants |
Other Pre-specified
Participants in Which endoAVF Maturation Was Achieved
Total time from successful endoAVF creation to one of the following: * Successful hemodialysis using 2 needle cannulation OR * Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound. Note: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.
Time frame: endoAVF creation through 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| endoAVF | Participants in Which endoAVF Maturation Was Achieved | 63 Participants |
| At 3 Months | Participants in Which endoAVF Maturation Was Achieved | 59 Participants |
| At 6 Months | Participants in Which endoAVF Maturation Was Achieved | 47 Participants |
| At Any Visit | Participants in Which endoAVF Maturation Was Achieved | 83 Participants |
Other Pre-specified
Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Assisted Primary Patency was defined in this study as The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure | 81 percentage of participants |
Other Pre-specified
Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure
Functional Patency in this study was defined as The interval of time from the first 2-needle dialysis utilizing the access until access abandonment.
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure | 95 percentage of participants |
Other Pre-specified
Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure
Secondary Patency in this study was defined as The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.
Time frame: endoAVF creation through 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| endoAVF | Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure | 91 percentage of participants |