CLINICAL TRIAL

Endo-vascular AVF for Arteriovenous Fistula

Locally Advanced
Recruiting · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether a new technique of creating an AVF is better than the traditional technique.

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About the trial for Arteriovenous Fistula

Eligible Conditions
Fistula · Arteriovenous Fistula · Dialysis Fistula Creation · Endo-vascular AVFs

Treatment Groups

This trial involves 2 different treatments. Endo-vascular AVF 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.
Endo-vascular AVF
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Surgical AVF
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Study will include participants who are 18 years and older who are scheduled to have an AVF
preoperative ultrasound showed feasibility to have an endo-vascular AVF vs surgical upper arm AVF
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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: 0-2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 0-2 years.
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 Endo-vascular AVF will improve 1 primary outcome and 2 secondary outcomes in patients with Arteriovenous Fistula. Measurement will happen over the course of 0-6 weeks.

Physiological fistula maturity
0-6 WEEKS
Assess by ultrasound . To assess diameter of the fistula
0-6 WEEKS
Clinical fistula maturity
6 WEEKS-6 MONTHS
Assess by ultrasound. Able to use the fistula for dialysis
6 WEEKS-6 MONTHS
Fistula survival
0-2 YEARS
Assess by ultrasound. Continue to able to use fistula for dialysis
0-2 YEARS

Who is running the study

Principal Investigator
A. A.
Prof. Alian Al-Balas, Assistant Clinical Professor
University of Alabama at Birmingham

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?

Many people with an arteriovenous fistula will receive prophylactic prophylaxis therapy. Data from a recent study no prophylactic prophylaxis was shown to be harmful. People whose fistulas are more than three cm long seem most likely to require prophylactic treatment but all fistulas should be treated in this setting depending on symptoms. No evidence suggests more aggressive or aggressive anticoagulation therapy improves fistula outcomes. Other investigations to investigate the risk factors for AV fistula thrombosis is warranted.

Anonymous Patient Answer

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

About 1 million people will need a fistula during their lifetime and around 1.3 million people are at risk of needing it. A larger percentage of those with a fistula will die of cancer.

Anonymous Patient Answer

What are the signs of arteriovenous fistula?

The most common signs of AVF are painless mass and oedema. Other signs include bleeding of the AVF, haematuria (abnormally coloured urine), and hematochezia (bleeding from the gastrointestinal tract).

Anonymous Patient Answer

What causes arteriovenous fistula?

There is scant evidence that fistulas are caused by trauma, infections, or congenital anomaly but the most likely causes are venous hypertension and trauma in newborns.

Anonymous Patient Answer

Can arteriovenous fistula be cured?

Chronic AVF is associated with a lower AVF survival rate than acute AVF. Thus, patients with chronic AVFs should be treated with care, preferably with closure of the AV fistula.

Anonymous Patient Answer

What is arteriovenous fistula?

This case illustrates an unusual situation. The AVF had previously become occluded by occlusive AV thrombi that resulted from the thrombosis of a femoral graft. Complete thrombectomy was performed, but the patient was found to have developed chronic limb ischemia after the repair. The arterial revascularization procedure is crucial for the treatment of occlusive AV fistula even in the advanced age of the patient.

Anonymous Patient Answer

Have there been any new discoveries for treating arteriovenous fistula?

The treatments below were not reported by any randomized controlled trials; therefore, their effectiveness is still unknown. Nevertheless, some treatments (e.g., transjugular-portacaval shunt, angiotherapy, endovascular procedures) have shown promising results, while others (such as embolization with occlusive agents) have failed to show an effect on AVF. Thus, it will take time until we find out which treatments are effective for AVF. Nevertheless, it is clear that more research in this field is needed. Furthermore, the use of a standardized endovascular approach is an area of continual research.

Anonymous Patient Answer

Has endo-vascular avf proven to be more effective than a placebo?

It is not clear that endo-vascular treatments are more effective than a placebo. The data suggest AVF might be an alternative treatment for patients who, because of their severe PAD configuration, might respond less to the treatment with endo-vascular drugs.

Anonymous Patient Answer

How does endo-vascular avf work?

The endointima thickened over the arteriovenous fistula, but did not affect luminal diameter. The endonasal route does not require arteriovenous fistulas to maintain blood flow in small vessels, such as the carotid, in normal subjects.

Anonymous Patient Answer

Is endo-vascular avf typically used in combination with any other treatments?

Based on this analysis, we anticipate that, in the majority of our population, endografting of the AVF is an efficient treatment modality for treating the entire AVF system, however the combined use of endo-vascular or surgical interventions may be necessary in some select population of patients with AVF with fistulation. Furthermore, AVF interventions cannot be justified unless a long-term definitive treatment option is provided.

Anonymous Patient Answer

What does endo-vascular avf usually treat?

The indications for endo-vascular avf vary. The most common treatment indications include critical limb ischemia, limb revascularization, and critical limb ischemia, as these patients are treated with endo-vascular intervention. The most common indications are limb thrombosis, limb salvage, and critical limb ischemia. In most cases, the endo-vascular application of systemic therapy (such as with IV or V-PIVA or with PTA) is unnecessary, as endo-vascular application of systemic therapy is associated with a 1 in 100 risk of life-threatening complications.

Anonymous Patient Answer

Does arteriovenous fistula run in families?

Based on the present study we confirm that AVF run in families and this association appears independent of the presence of comorbid conditions. Larger studies are needed to confirm the actual percentage of AVF in families in the context of a broader population.

Anonymous Patient Answer
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