Endovascular Stent Graft for Venous Obstruction

(WAVE Trial)

Not currently recruiting at 51 trial locations

Overseen By Susan Mann

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Merit Medical Systems, Inc.

Disqualifiers: Infection, Stroke, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Merit WRAPSODY Endovascular Stent Graft to determine its effectiveness for people with blocked or narrowed veins in their dialysis access. The study compares this stent graft to a standard procedure known as percutaneous transluminal angioplasty, which widens narrowed blood vessels. Individuals on long-term dialysis with a blocked or narrowed vein in their arm may be suitable candidates for this trial. The goal is to assess whether the new stent graft is safe and effective in improving blood flow in these veins. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Merit WRAPSODY Endovascular Stent Graft is safe for treating venous obstruction?

Research shows that the Merit WRAPSODY Endovascular Stent Graft is generally well-tolerated. Studies have shown positive safety results over a 12-month period. For example, one study found that 84.6% of patients had no blockage at the treated site after a year. Another study found that the WRAPSODY device was safe, with no major safety concerns compared to standard balloon procedures. While these findings are promising, all medical treatments can have some risks. Always consult a healthcare provider to understand the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WRAPSODY Endovascular Stent Graft because it offers a new way to address venous obstruction, which is currently treated with standard percutaneous transluminal angioplasty (PTA). Unlike PTA, which simply dilates the vein, the WRAPSODY stent graft provides a support structure that can help maintain open blood flow longer and potentially reduce the need for repeat procedures. Additionally, the stent graft is designed specifically for the venous system, which might offer better compatibility and performance compared to treatments primarily used in arteries. This could lead to improved outcomes and quality of life for patients with venous blockages.

What evidence suggests that the Merit WRAPSODY Endovascular Stent Graft is effective for treating venous obstruction?

Research has shown that the Merit WRAPSODY Endovascular Stent Graft effectively treats narrow or blocked veins in dialysis patients. One study found that the stent graft maintained good blood flow in 84.6% of patients after 12 months. This trial will compare the WRAPSODY Endovascular Stent Graft, which participants in the experimental arms may receive, with the standard procedure called angioplasty, used in the control group. Another study found the stent graft safe and effective for both peripheral and central veins, which are crucial for dialysis. These findings suggest that the WRAPSODY stent graft can improve blood flow for patients who need dialysis. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert Jones, MD

Principal Investigator

The Queen Elizabeth Hospital

Mahmood K. Razavi, MD

Principal Investigator

St. Joseph's Hospital, Orange, CA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject provides written informed consent

Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Target lesion has ≥50% stenosis.

Exclusion Criteria

I have an infection at my dialysis access site or a body-wide infection.

Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.

I was diagnosed with a stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with either the WRAPSODY Endovascular Stent Graft or standard percutaneous transluminal angioplasty (PTA)

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Merit WRAPSODY Endovascular Stent Graft

Trial Overview 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.

How Is the Trial Designed?

Group I: AVG Anastomosis Experimental Treatment 1 Intervention

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

Group II: AVF Peripheral study treatment group Experimental Treatment 1 Intervention

Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

Group III: AVF Peripheral control group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Merit Medical Systems, Inc.

Lead Sponsor

Trials

35

Recruited

3,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04540302

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8626397/

First Clinical Results of the Merit WRAPSODY™ Cell ... Results suggest that the study device is safe and effective for treatment of stenoses in the peripheral and central veins of arteriovenous access circuits.

3. merit.com merit.com/products/clinical-data/wrapsody-fih-study/

Merit WRAPSODY™ First-in-Human Study 12-Month Published Safety & Performance Results Graph Results 84.6% 12-Month Target Lesion Primary Patency Download the Study Summary Here

4. evtoday.com evtoday.com/articles/2025-aug-supplement/wrapsody-clinical-trial-program

WRAPSODY® Clinical Trial Program 12-month outcomes from the randomized arm of the Merit WRAPSODY AV Access Efficacy (WAVE) trial. Presented at: the Society of Interventional Radiology (SIR) ...

5. library.cirse.org library.cirse.org/cirse2024/crs/466-1-6-month-outcomes-from-the-merit-wrapsodytm-endovascular-stent-graft-to-percutaneous-transluminal-angioplasty-for-treatment-of-venous-outflow-circuit-stenosis-or-occlusion-in-hemodialysis-patients-the-wave-study

131.6 / 6-month outcomes from the Merit WRAPSODY ... 131.6 / 6-month outcomes from the Merit WRAPSODY™ endovascular stent graft to percutaneous transluminal angioplasty for treatment of venous outflow circuit ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240023B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The purpose of the study is to evaluate the long-term safety and effectiveness of the Merit. WRAPSODY® Endovascular Stent Graft. All subjects remaining in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0085253825000638

Clinical Trial Six-month safety and efficacy outcomes from ... Our study shows that among patients with stenosis in their AVF, the CIE was superior to PTA with respect to six-month TLPP and ACPP with no observed difference ...