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Stent Graft

Endovascular Stent Graft for Venous Obstruction (WAVE Trial)

N/A

Waitlist Available

Led By Mahmood K Razavi, MD

Research Sponsored by Merit Medical Systems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.

Subject is undergoing chronic hemodialysis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 and 24 months

Awards & highlights

WAVE Trial Summary

This trial is testing a new stent to treat blockages in the dialysis access outflow circuit. They want to see if it's safe and effective.

Who is the study for?

This trial is for adults over 18 who are on chronic hemodialysis with a life expectancy of at least one year. They must have an arm AVF or AVG and a specific type of blockage in their dialysis access site. Participants need to be willing to follow up and provide consent. Those with recent strokes, infections, heart issues, or pregnancy-related conditions can't join.Check my eligibility

What is being tested?

The study tests the Merit WRAPSODY Endovascular Stent Graft's safety and effectiveness against venous stenosis or occlusion in dialysis outflow circuits compared to PTA (angioplasty). It aims to see if this graft can improve blood flow for dialysis patients.See study design

What are the potential side effects?

While not specified here, endovascular stent grafts like the Merit WRAPSODY may cause side effects such as local pain, bleeding at the insertion site, infection risk increase, possible damage to blood vessels near the graft area.

WAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My target lesion is either new or has narrowed again without a stent.

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I am currently on long-term hemodialysis.

WAVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)

Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)

Secondary outcome measures

Proportion of subjects with Access Circuit Primary Patency (ACPP)

Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)

Proportion of subjects with Post-Procedure Secondary Patency

+2 more

WAVE Trial Design

3Treatment groups

Experimental Treatment

Group I: AVG AnastomosisExperimental Treatment1 Intervention

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

Group II: AVF Peripheral study treatment groupExperimental Treatment1 Intervention

Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

Group III: AVF Peripheral control groupExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PTA

2008

Completed Phase 4

~740

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merit Medical Systems, Inc.Lead Sponsor

30 Previous Clinical Trials

3,298 Total Patients Enrolled

3 Trials studying Venous Stenosis

546 Patients Enrolled for Venous Stenosis

Mahmood K Razavi, MDPrincipal InvestigatorSt. Joseph's Hospital, Orange, CA

1 Previous Clinical Trials

82 Total Patients Enrolled

Robert Jones, MDPrincipal InvestigatorThe Queen Elizabeth Hospital

3 Previous Clinical Trials

82 Total Patients Enrolled

Media Library

Merit WRAPSODY Endovascular Stent Graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04540302 — N/A

Venous Stenosis Research Study Groups: AVF Peripheral study treatment group, AVF Peripheral control group, AVG Anastomosis

Venous Stenosis Clinical Trial 2023: Merit WRAPSODY Endovascular Stent Graft Highlights & Side Effects. Trial Name: NCT04540302 — N/A

Merit WRAPSODY Endovascular Stent Graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540302 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are overseeing the management of this research?

"This medical research is being conducted in 38 various locations, such as Darien, Cleveland and Ashland. To reduce the need of travelling long distances it is beneficial to select a centre near your vicinity."

Answered by AI

Are there any open positions for volunteers in this clinical examination?

"According to clinicaltrials.gov, this medical trial is open for recruitment and has been since it was initially posted on March 9th 2021. The study was last updated on October 25th 2022."

Answered by AI

How many individuals are taking part in the research effort?

"Merit Medical Systems, Inc. will be managing this trial from several locations, including Vascular Care Connecticut in Darien and Cleveland Clinic in Ohio. This research necessitates 477 participants that meet the entry criteria for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

2021. "The Merit WRAPSODY AV Access Efficacy Study (WAVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540302.