Clinical trial NCT04626427: The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
Official title: The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Kidney Disease
Chronic Kidney Diseases
Kidney Failure
Kidney Insufficiency
Kidney Disease, Chronic
AV Fistula
Fistulas Arteriovenous
Keywords: Kidney Replacement Therapy
Hemodialysis
Vascular Access
Arteriovenous Access
Arteriovenous Fistula
Endovascular Arteriovenous Fistula
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 21
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: This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).

Detailed description: The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System when used for endovascular arteriovenous fistula (endoAVF) creations. Treated participants will be followed for 24-months post index procedure.

Eligibility criteria: Inclusion Criteria:

The participant must:

1. Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant).
2. Be able to and willing to comply with the CIP requirements, including clinical follow-up.
3. Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures.
4. Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician.
5. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography.
6. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography.
7. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee).
8. At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein.

Exclusion Criteria:

The participant must not have:

1. Active or nontreated hypercoagulable state.
2. Known bleeding diathesis.
3. Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee).
4. Known history of or current active intravenous drug abuse.
5. A "planned" major surgical procedure within 6 months following index procedure or major surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index procedure.
6. Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication.
7. Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication.
8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected).
9. Another medical condition, which, in the opinion of the PI (or authorized designee), may cause him / her to be non-compliant with the CIP, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of clinical investigation procedures and follow-up.
10. Current participation in an investigational drug or device clinical investigation that has not completed the clinical investigation treatment or that clinically interferes with the clinical investigation endpoints. Note: Investigations requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational.
11. Central venous stenosis or central vein narrowing ≥ 50% based on imaging, or any degree of central venous stenosis with accompanying signs or symptoms, on the same side as the planned AVF creation.
12. The absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via DUS or angiography.
13. Occlusion or stenosis ≥ 50%, or any degree of stenosis with accompanying signs or symptoms of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via DUS or angiography and as clinically determined by PI (or authorized designee).
14. Significantly compromised venous or arterial architecture (e.g. severe vessel calcification) or flow in the treatment arm as determined by the PI (or authorized designee) and DUS or angiography.
15. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the PI (or authorized designee).

Primary outcomes:
measure: Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
timeFrame: 30 days
measure: Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use
timeFrame: 6 months
Secondary outcomes:
measure: Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.
timeFrame: 6 months (24 months was also to be reported per the CIP but due to investigation early termination only data through 6 months was able to be evaluated).
measure: Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).
timeFrame: 6 weeks
measure: Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.
timeFrame: 6 months
measure: Cannulation Success - Presented as the Number of Days to Cannulation Success.
timeFrame: Through Investigation Early Termination
measure: Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency
timeFrame: 6 months (12 months per CIP but due to investigation early termination data is reported through 6 months instead due to the limited resultant data available at 12 months)
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital Bonheiden
city: Río
country: Greece
facility: University Hospital of Patras "Panagia I Voitheia"
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: University Health Network, Toronto
name: Charmaine Lok, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Queen Elizabeth Hospital
name: Nicholas Inston, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Panagiotis Kitrou, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: