Clinical trial NCT04540302: The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Official title: Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Venous Stenosis
Venous Occlusion
Keywords: AVF
AVG
AV fistula
AV graft
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study comprises 2 independent cohorts:

1. Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups)
2. Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent
* Subject is male or female, with an age ≥ 18 years at date of enrollment.
* Subject is willing to undergo all follow-up assessments.
* Subject has a life expectancy ≥ 12 months.
* Subject is undergoing chronic hemodialysis.
* Subject has either a mature AVF or AVG in the arm.
* Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
* Target lesion has ≥50% stenosis.
* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria:

* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
* Subject has a stroke diagnosis within 3 months prior to enrollment.
* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
* Target lesion is located within a stent / stent graft.

Primary outcomes:
measure: Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
timeFrame: 30 days
measure: Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency
timeFrame: 12 and 24 months
measure: Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with Access Circuit Primary Patency (ACPP)
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with Post-Procedure Secondary Patency
timeFrame: 6, 12 and 24 months
measure: Rates of procedure- and device-related adverse events involving the access circuit
timeFrame: Index procedure, 30 days, and months 6, 12 and 24.
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest Kidney institute (SKI) Vascular Center
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: Newark
country: United States
facility: Nephrology Associates
state: Delaware
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami
country: United States
facility: Open Access Miami, LLC
state: Florida
city: Oscala
country: United States
facility: Leesburg Vascular Access Center & Discovery Medical Research
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Chicago
country: United States
facility: Chicago Access Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital and Methodist Hospital
state: Indiana
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: West Roxbury
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
city: Flint
country: United States
facility: Michigan Vascular Access Center
state: Michigan
city: Vineland
country: United States
facility: Vascular Institute of Atlantic Medical Imaging
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Health
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Radiology
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Nephrology Raleigh Access
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University Pittsburg Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Providence Access Center
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health System Upstate
state: South Carolina
city: Dallas
country: United States
facility: Soltero Cardiovascular Research Center
state: Texas
city: Dallas
country: United States
facility: Renal Disease Research Institute
state: Texas
city: Fort Worth
country: United States
facility: PPG Health PA, DBA-Tarrant Vascular
state: Texas
city: Houston
country: United States
facility: Global Kidney Associates
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Katy
country: United States
facility: University of Texas Health - Memorial Hermann Katy Hospital
state: Texas
city: Pasadena
country: United States
facility: CDVA
state: Texas
city: Plano
country: United States
facility: Dallas Nephrology Associates
state: Texas
city: Virginia Beach
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Brasília
country: Brazil
facility: Instituto Santa Marta De Ensino E Pesquisa
city: Recife
country: Brazil
facility: Real Hospital Português de Beneficência em Pernambuco
city: Rio De Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: St. Joseph's Hospital, Orange, CA
name: Mahmood K Razavi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Queen Elizabeth Hospital
name: Robert Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: