(VENOS-3)

Multicenter Pivotal Study of the Velocity® Percutaneous Arteriovenous Fistula System

Multicenter Pivotal Study of the Velocity® Percutaneous Arteriovenous Fistula System

 (VENOS-3)

Information for Patients

Do you have advanced chronic kidney disease (CKD) or are on dialysis due to End-Stage Renal Disease (ESRD)?

Are you a candidate for the creation of an arteriovenous fistula (AVF) for hemodialysis?

What is the VENOS-3 Study?

 

The purpose of this research is to test effectiveness and safety of the Velocity System. This investigational device is used to create percutaneous AV fistula for hemodialysis access in patients with advanced CKD or ESRD.

Who is eligible for the study?

 

  • If you have advanced CKD or ESRD and are being considered for an arteriovenous fistula (AVF) you may be eligible for participation in this study.

What is a Percutaneous Arteriovenous Fistula (pAVF)?

 

  • An AV fistula is a link between an artery and a vein that enables blood access for dialysis.
  • A surgical AV fistula is made with a surgical procedure through an incision in the skin. During surgery, the doctor stitches an artery and vein in your arm together.
  • A percutaneous AV fistula (pAVF) is a newer procedure that creates an AV fistula using a minimally invasive surgical approach.
  • The pAVF is created on the inside part of the arm near where the elbow bends.
  • Similar to a surgical AV fistulas, two needles are inserted into the fistula to enable blood to go back and forth from the dialysis machine.

What is the Velocity System®?

 

 

  • The Velocity System creates a pAVF for hemodialysis access using a minimally invasive surgical procedure.
  • The Velocity System has two parts: a delivery tool and an implant.
  • The Velocity System creates an AV fistula using a small delivery tool and only needs local numbing.
  • Making a pAVF with the Velocity System leaves behind a permanent vascular implant. This lets blood from the artery flow into the vein, helping the vein grow larger. It is intended to work like a surgical AV fistula but with a minimally invasive surgical procedure instead.

Details for the study

 

  • The purpose of this study is to test effectiveness and safety of the Velocity® System.
  • The study has been reviewed by required Investigational Review Boards (IRBs).
  • The study will last for 5 years.
  • You will first have a physical exam, blood pressure check, medical history review, routine blood tests and an ultrasound of your arm.
  • If approved for the study, you will undergo a short, minimally invasive outpatient procedure where a small device implant is placed to create a pAVF.
  • During the study, an X-ray of your arm will be done two times to check the device for any problems. X-rays use a small amount of radiation. While usually safe, this extra radiation slightly increases the risk of cancer. You will also complete quality of life and satisfaction questionnaires.
  • You will have to come in for follow-up visits at the time points listed below after the procedure:

1 day
2 weeks
6 weeks
3 months
6 months
12 months
18 months
2 years
3 years
4 years
5 years

 

  • During each visit, your arm will be checked and medications reviewed. An ultrasound will also be performed to check the AV fistula in your arm.

What are the potential benefits of participating in the study?

 

  • The Velocity System can create an AVF with a minimally invasive surgical procedure, which might allow for quicker use in dialysis. This could mean you would need to use a catheter for less time, reducing the risk of problems like infections.
  • Future patients with end-stage kidney disease may also benefit from what is learned in this study.

Could being in this study hurt me?

 

Every medical procedure has risks. If you do not want to take these risks, please do not agree to join this study. The risks associated with participating in this study are similar to those of other minimally invasive dialysis access procedures, but we do not yet know how often or how serious these risks might be because there is not enough clinical experience with the Velocity System. Your doctor will talk about these risks with you before you consider signing an  Informed Consent to participate in the study. Your doctor and the healthcare team will be trained on how to properly use the device.

Potential risks and complications specific to Velocity device include:

  • Allergic response to the material the implant is made from.
  • Blockage of the implant or the vessel it is placed in, with either blood clot or scar tissue.
  • Infection of the implant requiring surgical removal.
  • A ballooning of the blood vessel wall where the implant is placed.
  • Migration of the implant to another location in the blood vessel or under the skin.
  • Fracture or breakage of the wire frame of the implant.

Risks shared with minimally invasive AV fistula procedures in general include the following:

  • Pain at the site where the implant is placed.
  • Failure to achieve fistula maturation preventing its use for hemodialysis.
  • Reduced blood flow to the hand.
  • Skin infection requiring treatment.
  • Bleeding and/or bruising at the site on your arm where the implant is placed, or where the puncture is made through the skin.
  • Inflammation or a cluster of immune cells (granuloma) at the access site or near the implant.
  • Need for additional surgical procedures to assist with the fistula maturation process.
  • Peripheral nerve injury.
  • Blood clot in the lung caused by a blocked vein in the arm.
  • Blood clot in an extremity blood vessel causing blockage of the vessel in the hand.
  • Need for an additional surgical intervention to resolve a complication which develops.
  • Short term or long-lasting breakdown or death of skin tissue near or around the access site.
  • Congestive heart failure, which is a long-term condition when your heart ca not pump blood well enough to meet your body’s needs.
  • Death

Potential risks associated with study procedures:

  • Blood draw: The risks of having blood drawn include pain, bruising, and fainting.
  • Ultrasound: Risks include discomfort from gel or pressure from the hand piece.
  • Regional anesthesia: Regional anesthesia can cause temporary discomfort from the needle puncture, allergic reactions, bruising or bleeding.
  • Two-view X-ray: It can expose you to a small amount of radiation, which may carry a slight risk of harm.
  • Use in Female Participants: If you are female, this procedure and treatments may have unknown or unexpected risks to an embryo or fetus if you are pregnant. Pregnant women or those who plan to become pregnant during the study cannot take part in the study. If you were to become pregnant during the study, please tell your doctor right away.

Alternative procedures:

The Velocity System is being tested as a new way to make AV fistulas for dialysis patientsas an option of minimally invasive surgical procedure. If you do not join this study, you have other choices:

  • Use an FDA-approved device to make an AV fistula with a minimally invasive surgical procedure.
  • Have traditional surgery.
  • Try other ways to access blood for dialysis, like an AV graft or a catheter.

You can talk to the study doctor about these options and they will explain the good and bad points of each of the above options.