The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Merit Medical Systems, Inc.357 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

357

Conditions

Venous Stenosis Venous Occlusion

Interventions

Merit WRAPSODY Endovascular Stent GraftDEVICE

Target lesion treated with stent graft placement

PTADEVICE

Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (43)

Outcomes

Primary Outcomes

Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)

Percentage 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

Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)

Percentage 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 Outcomes

Subjects With Target Lesion Primary Patency

Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 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: 12 months

Subjects With Target Lesion Primary Patency

Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 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.

Data from ClinicalTrials.gov

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Southwest Kidney institute (SKI) Vascular Center

Tempe, Arizona, United States

Pima Heart and Vascular

Tucson, Arizona, United States

St. Joseph Hospital

Orange, California, United States

Vascular Care Connecticut

Darien, Connecticut, United States

Nephrology Associates

Newark, Delaware, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Open Access Miami, LLC

Miami, Florida, United States

Leesburg Vascular Access Center & Discovery Medical Research

Oscala, Florida, United States

Coastal Vascular and Interventional

Pensacola, Florida, United States

Chicago Access Center

Chicago, Illinois, United States

...and 33 more locations

Time frame: 24 months

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.

Time frame: 6 months

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.

Time frame: 12 months

Subjects With Assisted Target Lesion Primary Patency (aTLPP)

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.

Time frame: 24 months

Subjects With Access Circuit Primary Patency (ACPP)

Time frame: 6 months

Subjects With Access Circuit Primary Patency (ACPP)

Time frame: 12 months

Subjects With Access Circuit Primary Patency (ACPP)

Time frame: 24 months

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.

Time frame: 6 months

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.

Time frame: 12 months

Subjects With Post-Procedure Secondary Patency

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.

Time frame: 24 months

Rates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at index procedure

Time frame: Index procedure