CLINICAL TRIAL

Treatment for Arteriovenous Fistula

Newly Diagnosed
Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a device and procedure can improve the patency of dialysis fistulae.

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About the trial for Arteriovenous Fistula

Eligible Conditions
Fistula · Arteriovenous Fistula · Arteriovenous Fistula Stenosis

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
FLEX Vessel Prep System
DEVICE
Control Group 2
Angioplasty
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Arteriovenous Fistula or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The text suggests that the lesion can be treated as a single entity. show original
The target vessel diameter is 4.0 - 12.0 mm, estimated visually. show original
The patient has a target lesion that is ≤ 100 mm in length, which may include a tandem lesion. show original
The total lesion length, including the 30 mm gap, is ≤ 100 mm. show original
The target AV fistula has been successfully used for dialysis eight times out of twelve over the course of four weeks. show original
The patient already had an AV fistula created before the current procedure. show original
The patient is over the age of 21. show original
The patient has a life expectancy of more than one year. show original
A patient has a new and/or unstented lesion located between 2 cm from the arteriovenous anastomosis and the axillosubclavian junction, with a stenosis of at least 50%. show original
Separated by a gap of 3 cm or less. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 and 6 Months
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 6 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 and 6 Months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes and 13 secondary outcomes in patients with Arteriovenous Fistula. Measurement will happen over the course of Procedure.

Device Success
PROCEDURE
Defined as successful delivery, treatment, and retrieval of the FLEX Vessel Prep device at index procedure.
PROCEDURE
Balloon opening pressure
PROCEDURE
Defined as minimum inflation pressure required to efface target lesion noting parallel balloon walls.
PROCEDURE
Primary Safety Endpoint: Serious Adverse Event Rate
30 DAYS
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
30 DAYS
Clinical Success
30 DAYS
Defined as resumption of successful dialysis for at least one session after index procedure.
30 DAYS
Maximum balloon pressure
PROCEDURE
Maximum pressure of angioplasty balloon(s) required during the interventional procedure to treat target lesion.
PROCEDURE
Patient Reported Pain
PROCEDURE
Patient Reported Pain during the interventional procedure reported via Numerical Rating Scale (NRS).
PROCEDURE
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Patient Q & A Section

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

What are common treatments for arteriovenous fistula?

Most patients develop post-operative wounds or hematomas as a result of a arteriovenous fistula, and patients with poor wound healing should not attempt to create their own fistula. Patients undergoing endovascular treatment of a synthetic arteriovenous fistula and a vein bypass may receive antibiotics and anticoagulants to prevent thrombosis of the graft. Local wound excision can be used to treat venous leg ulcers in patients whose lesions are too large to excise with a scalpel. Stenting of arteries can be used to treat arteriovenous malformations or to treat aortoarterial fistulas.

Anonymous Patient Answer

How many people get arteriovenous fistula a year in the United States?

The prevalence of arteriovenous fistula use in the U.S. is 0.8%, or approximately 1.3 million cases annually. This number is considerably higher than the number of end-stage hemodialysis patients. Furthermore, approximately 740,000 patients currently receiving hemodialysis in the United States (approximately 5% of the total U.S. population) will lose the access they have after 1 year.

Anonymous Patient Answer

Can arteriovenous fistula be cured?

In advanced renal failure there is a high risk of secondary venous thrombosis, which is often permanent. A well-established vascular access system reduces thrombotic complications and can be considered a cure for patients with renal failure.

Anonymous Patient Answer

What are the signs of arteriovenous fistula?

The signs of an arteriovenous fistula include bleeding or purpura at the site of insertion of the cannula. The colour of blood and skin surrounding a fistula may be abnormal. Complications of an arteriovenous fistula may include blood clots. To minimize the risk of blood clots and the risk of infection, heparin therapy may be used. The size of the vessels that supply our organs is essential when discussing the diagnosis of arteriovenous fistula. To obtain this information, blood vessels will usually be examined before treatment is started. An abdominal x-ray may aid in the diagnosis of venous or arterial malformations.

Anonymous Patient Answer

What causes arteriovenous fistula?

It is generally agreed that arteriovenous shunts are the result of abnormal fistula formation where arteries and veins branch and become mixed, and thus form a fistula.

Anonymous Patient Answer

What is arteriovenous fistula?

Data from a recent study the most common complications of AVFs were arterial stenosis and the associated vascular access-related deaths. AVF, though not always mandatory, is still mandatory to ensure a continuous access in diabetic and malnourished patients.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

The current evidence does not support the assumption that adjunctive treatment with the sestamibi scan is more effective than no treatment for inducing an increase in blood supply to the kidneys.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

As for other treatments, different combinations of treatments are utilized in the actual practice of medicine. Treatments used for vascular-related maladies in this study include surgical procedures, and they were utilized in combination: with treatments such as embolization, stenting, angioplasty, and sclerotherapy.

Anonymous Patient Answer

What is the primary cause of arteriovenous fistula?

As a conclusion, the most likely cause of arteriovenous fistula in our city was an infectious and inflammatory process. Patients with high blood glucose levels and heart failure tended to have arteriovenous fistulas, and an increase in the number of fistulas with time was seen.

Anonymous Patient Answer

How does treatment work?

The outcomes for treatment of arteriovenous fistulae vary, as does the time from treatment to first intervention. Treatment is better tolerated and results in a better outcome when it starts promptly and is continued. A better outcome may be achieved in treatment centers or centers using the latest techniques.

Anonymous Patient Answer

Does arteriovenous fistula run in families?

AVFs occur as a result of genetic alterations in a small number of patients in our series. The familial pattern of AVF suggested that AVF are in an inherited state. However, genetic analyses need to be completed to understand the causes of AVF.

Anonymous Patient Answer

What is treatment?

The primary purpose of treatment is to improve blood clotting. For example, anticoagulants and antiplatelets are used to treat patients with venous or arterial thromboembols, and in many patients with atrial fibrillation also. Antiplatelets are also given in patients who are also at risk for arterial thrombosis. Patients who have strokes related to arteriovenous malformations also undergo treatment, usually involving antiplatelet medications.

Anonymous Patient Answer
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