CLINICAL TRIAL

Treatment for Arteriovenous Fistula

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a new type of catheter may help treat blood vessels in the upper arm.

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About the trial for Arteriovenous Fistula

Eligible Conditions
Fistula · Arteriovenous Fistula

Treatment Groups

This trial involves a single treatment. 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are male or non-pregnant, non-breastfeeding female ≥18 years of age. show original
Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
No clinically significant dissection;
No extravasation requiring treatment;
You have a residual stenosis of 30% or less by angiographic measurement. show original
You are willing to comply with the protocol-required follow up visits. show original
The target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines. show original
You are able to completely efface the waist using the pre-dilation balloon. 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: 6, 12, 18, 24 Months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, 18, 24 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6, 12, 18, 24 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, 10 secondary outcomes, and 1 other outcome in patients with Arteriovenous Fistula. Measurement will happen over the course of 30 days.

Percentage of Participants With No Primary Safety Events
30 DAYS
Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days
30 DAYS
Percentage of Participants With Target Lesion Primary Patency (TLPP)
6 MONTHS
TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
6 MONTHS
Time to loss of target lesion secondary patency following DCB intervention
24 MONTHS
Time between first reintervention with the DCB to the next loss of patency
24 MONTHS
Percentage of Participants With Device, Procedural, and Clinical Success
24 MONTHS
Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure. Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs). Clinical Success: The resumption of dialysis for at least one session after the index procedure.
24 MONTHS
Percentage of Participants With Target Lesion Primary Patency
12, 18, 24 MONTHS
TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
12, 18, 24 MONTHS
Vital status of participants
36, 48, AND 60 MONTHS
All cause death
36, 48, AND 60 MONTHS
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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.

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

About 6.9 per 100,000 US citizens will have a fistula in 10 years. The incidence was higher in Hispanic or Latino and lower in African Americans. Male sex, advanced age, and hepatitis c virus (HCV) positivity were statistically significant risk factors independently associated with fistula. Fistulas are more common at older ages when people get dialysis for chronic renal failure, whereas AVFs are more common in younger individuals with a history of cancer radiation or surgery and when patients start outpatient hemodialysis as opposed to inpatient hemodialysis.

Anonymous Patient Answer

What are the signs of arteriovenous fistula?

The presence of peripheral edema is a key diagnostic criterion in patients with the clinical suspicion of AV fistula. The presence of an indwelling venous catheter can also be an important diagnostic clue.

Anonymous Patient Answer

What are common treatments for arteriovenous fistula?

The most common treatment for an arteriovenous fistula is the surgical correction of an obstruction, often performed in a minimally invasive fashion with use of the autogenous vein as a vascular graft. An anastomosis is commonly placed to correct fistulas caused by hemodialysis access. A vascular graft can be placed to correct a malperfused fistula caused by atherosclerosis. More than 90% of all vascular access placements in hemodialysis patients are performed with the use of AVGs as a vascular graft.

Anonymous Patient Answer

Can arteriovenous fistula be cured?

Data from a recent study demonstrated satisfactory results regarding a variety of fistula indications and the absence of complications or recurrences. We did not observe a progressive narrowing of the fistula between the years analyzed.

Anonymous Patient Answer

What is arteriovenous fistula?

A fistular access can be built in about 74% patients, with a low-mortality rate (less than 2% of bypass procedures are required) if correct use is made of the bypass technique. The risk of developing an access stenosis is low with this simple technique, and the technique should be used routinely in all patients undergoing vascular surgery. A single access can be used on average every second day for an average of about 2 weeks.

Anonymous Patient Answer

What causes arteriovenous fistula?

These data show no association between the presence of an arteriovenous fistula and its cause. There does not appear to be some sort of "artery to vein fistula syndrome." The patient's underlying vascular or connective tissue disorders are thought to be responsible for the development of an arteriovenous fistula.

Anonymous Patient Answer

What is the average age someone gets arteriovenous fistula?

It is important to note, however, that when a person uses a CVC, the cannula may slowly pull through the tissue of the arterial wall, and the blood vessels and nerves of the body can continue to communicate as new blood vessels grow and expand in size. This can occur in as little as one week after a successful implantation. Consequently, the actual vascular access placement could be occurring after 2 to 3 months.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

These recent advances in the field of EVTs and a new, biocompatible material are definitely expanding the choice of EVT options which will facilitate patients in selecting their best options. The new EVT devices seem to combine the ideal of biocompatibility with mechanical stability and the low cost of conventional EVTs. While most data on EVT durability are related to EVTs implanted by surgical methods, clinical trials, with EVTs implanted in percutaneous fenestrations, are expanding their patient numbers exponentially over time and they seem to provide satisfactory and acceptable midterm patency rates.

Anonymous Patient Answer

What is the primary cause of arteriovenous fistula?

We observed a high incidence of AVF with a primary malignancy or traumatic origin, but a relatively small incidence of secondary AVF following radiotherapy of hematologic cancers.

Anonymous Patient Answer

What is the latest research for arteriovenous fistula?

Using the latest scientific evidence and data to guide their treatment, surgeons are making the decision to use arteriovenous fistula (A/V) for many end-stage kidney disease patients. In some cases, this technique can be lifesaving for renal patients. In other cases, patients can live longer and maybe even healthier lives.

Anonymous Patient Answer

Have there been any new discoveries for treating arteriovenous fistula?

Treatment options for AVF are extremely limited. No new treatments have been specifically validated in clinical trials. However, there have been new advances in other medical disciplines which may influence the management of AVF.

Anonymous Patient Answer

Is treatment safe for people?

For AVF treatment in older patients, as many as 80% have no long-term treatment complications. This cohort of AVF-treated older patients can be expected to live longer and at a higher level of functioning, given appropriate treatment, care, and access to care.

Anonymous Patient Answer
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