everlinQ endoAVF Post Market Study

Chronic Kidney Disease Clinical Trial

Official title:

everlinQ endoAVF Post Market Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02682420
• Other study ID #: CD-0018
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: August 2019

Study information

• Verified date: November 2021
• Source: TVA Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• everlinQ endoAVF System

Locations

Country	Name	City	State
Canada	Providence Health Care Society	Vancouver	British Columbia
Germany	University Hospital Carl Gustav Carus	Dresden
Germany	Dominikus Hospital	Düsseldorf
Germany	University of Frankfurt	Frankfurt
Germany	University of Leipzig	Leipzig
Germany	University of Mannheim	Mannheim
Germany	St. Franziskus-Hospital Münster	Münster
United Kingdom	University Hospitals Birmingham	Birmingham
United Kingdom	Oxford University Hospitals - NHS Foundation Trust	Headington	Oxford
United Kingdom	St. George's University	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
TVA Medical Inc.

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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".	endoAVF creation through 6 Months
Other	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".	endoAVF creation through 6 Months
Other	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".	endoAVF creation through 6 Months
Other	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.	endoAVF creation to cannulation
Other	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.	endoAVF creation
Other	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.	endoAVF creation
Other	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.	endoAVF creation through 6 Months
Other	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.	endoAVF creation through 6 months
Other	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.	endoAVF creation through 6 Months
Other	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	endoAVF creation through 6 Months
Other	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	endoAVF creation through 6 Months
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".	endoAVF creation through 6 months