Clinical trial NCT02682420: everlinQ endoAVF Post Market Study
Official title: everlinQ endoAVF Post Market Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: TVA Medical Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 months
Secondary outcomes:
Other outcomes:
measure: Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 Months
measure: Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 Months
measure: Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 Months
measure: Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF
timeFrame: endoAVF creation to cannulation
measure: Number of Participants With Procedural Success at the Index Procedure
timeFrame: endoAVF creation
measure: Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)
timeFrame: endoAVF creation
measure: Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)
timeFrame: endoAVF creation through 6 Months
measure: Participants in Which endoAVF Maturation Was Achieved
timeFrame: endoAVF creation through 6 months
measure: Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points
timeFrame: endoAVF creation through 6 Months
measure: Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 Months
measure: Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure
timeFrame: endoAVF creation through 6 Months
Locations:
city: Vancouver
country: Canada
facility: Providence Health Care Society
state: British Columbia
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Dominikus Hospital
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mannheim
country: Germany
facility: University of Mannheim
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster
city: Headington
country: United Kingdom
facility: Oxford University Hospitals - NHS Foundation Trust
state: Oxford
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: London
country: United Kingdom
facility: St. George's University
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: University Hospitals Birmingham NHS
name: Nicholas Inston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Frankfurt, Germany
name: Thomas Schmitz-Rixen, MD
role: PRINCIPAL_INVESTIGATOR
References: