What is the mechanism of action of this treatment?

The BD® WavelinQ™ EndoAVF System is a minimally invasive treatment for creating arteriovenous fistulas (AVFs) for dialysis access. This system uses an endovascular approach, employing catheters and radiofrequency energy to create a connection between an artery and a vein, facilitating efficient blood flow for hemodialysis. The primary mechanism of action involves precise, controlled tissue fusion without the need for open surgery, reducing recovery time and complications. This is significant for AVF patients as it offers a safer, less invasive option with potentially better outcomes and quicker return to dialysis, improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for the creation of arteriovenous fistula (AVF) for dialysis access, such as the BD® WavelinQ™ EndoAVF System, typically involve endovascular techniques. Known side effects of these procedures can include bleeding, infection, and thrombosis at the access site. Other potential complications may include stenosis (narrowing of the blood vessels), which can affect the long-term patency of the fistula, and issues related to the maturation of the fistula, which may require additional interventions. Overall, while these procedures are generally safe, patients should be monitored for these potential adverse effects.

What prior FDA approvals exist?

The BD® WavelinQ™ EndoAVF System is an FDA-approved device designed for the creation of arteriovenous fistulas (AVFs) in patients requiring dialysis. This system uses an endovascular approach to create AVFs, which is less invasive compared to traditional surgical methods. Other similar FDA-approved devices include the Ellipsys® Vascular Access System, which also employs a minimally invasive technique to create AVFs for dialysis access. These devices represent advancements in the treatment of end-stage renal disease by providing alternative methods for AVF creation, aiming to improve patient outcomes and reduce complications associated with traditional surgical procedures.

What other types of research exist?

Promising novel alternatives to the BD® WavelinQ™ EndoAVF System for the creation of arteriovenous fistula in dialysis patients include: 1) Ellipsys® Vascular Access System, which uses a minimally invasive, single catheter approach to create a percutaneous AVF. 2) Novel endovascular techniques such as the use of drug-coated balloons and stents to enhance AVF maturation and patency. 3) Advances in bioengineered vascular grafts that aim to improve long-term outcomes and reduce complications associated with traditional AVF creation.

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Endovascular Device

EndoAVF Creation for Chronic Kidney Failure (CONNECT-AV Trial)

N/A

Recruiting

Led By Paul Kreienberg, MD

Research Sponsored by C. R. Bard

Eligibility Criteria Checklist

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

Must have

At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein

Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis

Must not have

The subject is in a hypercoagulable state

The subject has known bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

Awards & highlights

Summary

This trial studies the BD® WavelinQ™ EndoAVF System, a device that creates a connection between an artery and a vein. It is designed for patients who need dialysis. The device helps make a new pathway for blood flow, which is essential for the dialysis process.

Who is the study for?

This study is for adults over 18 with chronic kidney failure who are on dialysis or will need it within 6 months. They must have veins and arteries of certain sizes, be willing to follow the study plan, and not have any conditions that could interfere with the trial or reduce life expectancy.

What is being tested?

The BD® WavelinQ™ EndoAVF System is being tested in this study. It's a device used to create an arteriovenous fistula (a connection between an artery and vein) without traditional surgery, which patients needing dialysis require.

What are the potential side effects?

While specific side effects aren't listed here, creating an AV fistula can sometimes lead to issues like clotting at the site, infection, arm swelling due to blood flow changes, or narrowing of the vessels.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a vein in my forearm that is at least 2.5 mm wide and connects to the target site.

Select...

I have permanent kidney failure and am on dialysis or will need it soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood clots more easily than normal.

Select...

I have a condition that causes abnormal bleeding.

Select...

I have a narrowed vein by more than 50% where my endoAVF is planned.

Select...

My blood flow in the arm to be treated is significantly reduced, confirmed by tests.

Select...

I haven't had major surgery in the last 30 days and don't plan any in the next 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device- and procedure-related serious adverse events (SAE)

Secondary study objectives

Assisted Primary Patency

Cannulation Success

Functional Cannulation Success

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EndoAVFExperimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The BD® WavelinQ™ EndoAVF System is a minimally invasive treatment for creating arteriovenous fistulas (AVFs) for dialysis access. This system uses an endovascular approach, employing catheters and radiofrequency energy to create a connection between an artery and a vein, facilitating efficient blood flow for hemodialysis. The primary mechanism of action involves precise, controlled tissue fusion without the need for open surgery, reducing recovery time and complications. This is significant for AVF patients as it offers a safer, less invasive option with potentially better outcomes and quicker return to dialysis, improving overall quality of life.