The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Venous Occlusion Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04540302
• Other study ID #: CVO-P3-20-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 357
• Est. completion date: January 2026
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Venous Occlusion
• Venous Stenosis

Intervention

Device:
• Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
• PTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

Locations

Country	Name	City	State
Brazil	Instituto Santa Marta De Ensino E Pesquisa	Brasília
Brazil	Real Hospital Português de Beneficência em Pernambuco	Recife
Brazil	Hospital Universitário Pedro Ernesto	Rio De Janeiro
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Canada	Toronto General Hospital	Toronto
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Royal London Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Lister Hospital	Stevenage
United States	King's Daughters Medical Center	Ashland	Kentucky
United States	UNC Health	Chapel Hill	North Carolina
United States	Charlotte Radiology	Charlotte	North Carolina
United States	Chicago Access Center	Chicago	Illinois
United States	Northwestern Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Renal Disease Research Institute	Dallas	Texas
United States	Soltero Cardiovascular Research Center	Dallas	Texas
United States	Vascular Care Connecticut	Darien	Connecticut
United States	Michigan Vascular Access Center	Flint	Michigan
United States	PPG Health PA, DBA-Tarrant Vascular	Fort Worth	Texas
United States	Prisma Health System Upstate	Greenville	South Carolina
United States	Global Kidney Associates	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Indiana University Hospital and Methodist Hospital	Indianapolis	Indiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	University of Texas Health - Memorial Hermann Katy Hospital	Katy	Texas
United States	Open Access Miami, LLC	Miami	Florida
United States	Nephrology Associates	Newark	Delaware
United States	Leesburg Vascular Access Center & Discovery Medical Research	Ocala	Florida
United States	St. Joseph Hospital	Orange	California
United States	CDVA	Pasadena	Texas
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	University Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Dallas Nephrology Associates	Plano	Texas
United States	Providence Access Center	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	North Carolina Nephrology Raleigh Access	Raleigh	North Carolina
United States	Southwest Kidney institute (SKI) Vascular Center	Tempe	Arizona
United States	Pima Heart and Vascular	Tucson	Arizona
United States	Vascular Institute of Atlantic Medical Imaging	Vineland	New Jersey
United States	Sentara Vascular Specialists	Virginia Beach	Virginia
United States	Brigham and Women's Faulkner Hospital	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Primary	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.	6 months
Secondary	Proportion of subjects with Target Lesion Primary Patency		12 and 24 months
Secondary	Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)		6, 12 and 24 months
Secondary	Proportion of subjects with Access Circuit Primary Patency (ACPP)		6, 12 and 24 months
Secondary	Proportion of subjects with Post-Procedure Secondary Patency		6, 12 and 24 months
Secondary	Rates of procedure- and device-related adverse events involving the access circuit		Index procedure, 30 days, and months 6, 12 and 24.