Endovascular Stent Graft for Venous Obstruction

(WAVE Trial)

Recruiting at 50 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

357 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Merit WRAPSODY Endovascular Stent Graft for venous obstruction?

The Merit WRAPSODY Endovascular Stent Graft has shown promise in treating access circuit stenosis (narrowing of blood vessels) in patients undergoing dialysis, as it was evaluated for safety and effectiveness in a study. Additionally, stent grafts in general have been found to reduce the need for repeated interventions and improve the function of blood vessel access in similar conditions. ^{1 2 3 4 5}

Is the Merit WRAPSODY Endovascular Stent Graft safe for use in humans?

The Merit WRAPSODY Endovascular Stent Graft has been evaluated for safety in a study involving patients with arteriovenous fistula and graft access circuit stenosis, showing it is safe for use in these conditions. ^{2 3 6 7 8}

How is the Merit WRAPSODY Endovascular Stent Graft treatment different from other treatments for venous obstruction?

The Merit WRAPSODY Endovascular Stent Graft is unique because it is designed to be cell-impermeable, which helps prevent the narrowing of blood vessels (stenosis) in patients undergoing hemodialysis. This feature may offer a more effective and safer option for maintaining blood flow compared to traditional treatments that do not have this cell-impermeable property. ^{2 3 9 10 11}

Research Team

Robert Jones, MD

Principal Investigator

The Queen Elizabeth Hospital

Mahmood K. Razavi, MD

Principal Investigator

St. Joseph's Hospital, Orange, CA

Eligibility Criteria

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

I am 18 years old or older.

Subject provides written informed consent

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Simultaneous Iliac Vein Bovine Pericardial Patch Venoplasty and Creation of PTFE Lower Limb Arteriovenous Fistula Graft for Rescue Vascular Access. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Early cannulation of the Hemodialysis Reliable Outflow graft. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pre-emptive or reactive treatment, angioplasty or stent-graft? The outcome for interventions for venous stenosis in early-cannulation arteriovenous grafts. [2023]

5. Bulgaria pubmed.ncbi.nlm.nih.gov

[Endovascular prostheses]. [2016]

6. Japan pubmed.ncbi.nlm.nih.gov

A novel biodegradable external mesh stent improved long-term patency of vein grafts by inhibiting intimal-medial hyperplasia in an experimental canine model. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of intragraft stenosis in hemodialysis grafts with Supera stents: A retrospective study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The VEST External Support for Saphenous Vein Grafts in Coronary Surgery: A Review of Randomized Clinical Trials. [2023]

9. Poland pubmed.ncbi.nlm.nih.gov

A new external stent - intimal proliferation and apoptosis in the vein graft in the animal model. [2009]

10. England pubmed.ncbi.nlm.nih.gov

The effect of 'non-critical' ( [2007]

11. United States pubmed.ncbi.nlm.nih.gov

Results of Stent Graft Placement to Treat Cephalic Arch Stenosis in Hemodialysis Patients with Dysfunctional Brachiocephalic Arteriovenous Fistulas. [2018]