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The Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)

Primary Purpose

Venous Stenosis, Venous Occlusion

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Merit WRAPSODY Endovascular Stent Graft
PTA
Sponsored by
Merit Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Stenosis focused on measuring AVF, AVG, AV fistula, AV graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Kidney institute (SKI) Vascular Center
  • Pima Heart and Vascular
  • St. Joseph Hospital
  • Vascular Care Connecticut
  • Nephrology Associates
  • First Coast Cardiovascular Institute
  • Open Access Miami, LLC
  • Leesburg Vascular Access Center & Discovery Medical Research
  • Coastal Vascular and Interventional
  • Chicago Access Center
  • Northwestern Medical Center
  • Indiana University Hospital and Methodist Hospital
  • King's Daughters Medical Center
  • Brigham and Women's Faulkner Hospital
  • Michigan Vascular Access Center
  • Vascular Institute of Atlantic Medical Imaging
  • UNC Health
  • Charlotte Radiology
  • NC Heart and Vascular Research
  • North Carolina Nephrology Raleigh Access
  • Cleveland Clinic
  • University Pittsburg Medical Center
  • Providence Access Center
  • Prisma Health System Upstate
  • Soltero Cardiovascular Research Center
  • Renal Disease Research Institute
  • PPG Health PA, DBA-Tarrant Vascular
  • Global Kidney Associates
  • Houston Methodist Hospital
  • University of Texas Health - Memorial Hermann Katy Hospital
  • CDVA
  • Dallas Nephrology Associates
  • Sentara Vascular Specialists
  • Instituto Santa Marta De Ensino E Pesquisa
  • Real Hospital Português de Beneficência em Pernambuco
  • Hospital Universitário Pedro Ernesto
  • Instituto Dante Pazzanese de Cardiologia
  • Toronto General Hospital
  • Queen Elizabeth Hospital
  • Dorset County Hospital
  • Royal London Hospital
  • Churchill Hospital
  • Lister Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

AVF Peripheral study treatment group

AVF Peripheral control group

AVG Anastomosis

Arm Description

Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)

All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft

Outcomes

Primary Outcome Measures

Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

Secondary Outcome Measures

Proportion of subjects with Target Lesion Primary Patency
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Post-Procedure Secondary Patency
Rates of procedure- and device-related adverse events involving the access circuit

Full Information

First Posted
September 1, 2020
Last Updated
October 9, 2023
Sponsor
Merit Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04540302
Brief Title
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Acronym
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
January 29, 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit Medical Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stenosis, Venous Occlusion
Keywords
AVF, AVG, AV fistula, AV graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study comprises 2 independent cohorts: Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups) Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVF Peripheral study treatment group
Arm Type
Experimental
Arm Description
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Arm Title
AVF Peripheral control group
Arm Type
Other
Arm Description
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
Arm Title
AVG Anastomosis
Arm Type
Experimental
Arm Description
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Intervention Type
Device
Intervention Name(s)
Merit WRAPSODY Endovascular Stent Graft
Intervention Description
Target lesion treated with stent graft placement
Intervention Type
Device
Intervention Name(s)
PTA
Intervention Description
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
Primary Outcome Measure Information:
Title
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
Description
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Time Frame
30 days
Title
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
Description
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of subjects with Target Lesion Primary Patency
Time Frame
12 and 24 months
Title
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time Frame
6, 12 and 24 months
Title
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time Frame
6, 12 and 24 months
Title
Proportion of subjects with Post-Procedure Secondary Patency
Time Frame
6, 12 and 24 months
Title
Rates of procedure- and device-related adverse events involving the access circuit
Time Frame
Index procedure, 30 days, and months 6, 12 and 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmood K Razavi, MD
Organizational Affiliation
St. Joseph's Hospital, Orange, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Jones, MD
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Kidney institute (SKI) Vascular Center
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Pima Heart and Vascular
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Vascular Care Connecticut
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Nephrology Associates
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Open Access Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Leesburg Vascular Access Center & Discovery Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Coastal Vascular and Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Chicago Access Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60559
Country
United States
Facility Name
Northwestern Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University Hospital and Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
King's Daughters Medical Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Brigham and Women's Faulkner Hospital
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Michigan Vascular Access Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Vascular Institute of Atlantic Medical Imaging
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
80360
Country
United States
Facility Name
UNC Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Radiology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28202
Country
United States
Facility Name
NC Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
North Carolina Nephrology Raleigh Access
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Providence Access Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Prisma Health System Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Soltero Cardiovascular Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
PPG Health PA, DBA-Tarrant Vascular
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Global Kidney Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health - Memorial Hermann Katy Hospital
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
CDVA
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Dallas Nephrology Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sentara Vascular Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Instituto Santa Marta De Ensino E Pesquisa
City
Brasília
Country
Brazil
Facility Name
Real Hospital Português de Beneficência em Pernambuco
City
Recife
Country
Brazil
Facility Name
Hospital Universitário Pedro Ernesto
City
Rio De Janeiro
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
Country
Brazil
Facility Name
Toronto General Hospital
City
Toronto
Country
Canada
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

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