FACING ANOTHER AORTIC ARCH SURGERY?
Have you had an aortic arch surgery in the past?
You probably know that you are at risk of needing additional surgeries in the future.
Having a prior aortic arch surgery and/or other risk factors can reduce your treatment options for another aortic arch surgery.
The TRIOMPHE Study is now enrolling patients at sites across the US to investigate the NEXUS™ Aortic Arch Stent Graft System. This innovative device is specifically designed for a much less invasive procedure.
ABOUT THORACIC AORTIC ARCH DISEASE
The NEXUS™ Aortic Arch Stent Graft System was specifically engineered for minimally-invasive total arch repair to overcome the challenges of the aortic arch anatomy.
NEXUS™ is delivered by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). This delivery method is called an endovascular approach.
NEXUS™ is designed to make a minimally-invasive repair possible for more patients while reducing the risks of surgery.
Frequently asked questions
Can I receive the NEXUS™ device without joining the study?
The NEXUS™ Aortic Arch Stent Graft System is being studied and is not approved by the FDA. The NEXUS™ Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The FDA has approved the use of the NEXUS™ Aortic Arch Stent Graft System for use as part of this study. The NEXUS™ Aortic Arch Stent Graft System is only available through the clinical study in the United States.
How often will I be seen?
You will need to visit the doctor’s office for study follow-up visits approximately seven (7) times over the course of the study.
Will my personal health information be kept private?
Your study-related medical information will be held confidential as much as possible and will not be made publicly available. Local, country, state, and federal privacy laws will be followed; however, we cannot guarantee absolute confidentiality.
Are there any potential risks?
It is possible that your condition may not improve and could worsen if you take part in this study. There may be side effects that are not known at this time. Complications may occur at any time. There are possible risks and side effects connected to any medical procedure. It is believed the NEXUS™ Aortic Arch Stent Graft System has similar possible risks and side effects to other available devices dedicated to treatment of the descending aorta. Potential risks which may be associated with the NEXUS™ Aortic Arch Stent Graft System include, but are not limited to:
• Abscess formation – formation of a swollen lump
• Acute respiratory distress syndrome – rapidly progressing shortness of breath due to fluid buildup in your lungs.
• Adverse foreign body response – immune system reaction
• Adverse reaction to anesthesia - unfavorable response to anesthesia
• Allergies – causing your immune system to react abnormally to a foreign substance
• Amputation - surgical removal of a limb
• Aneurysm enlargement or rupture
• Aortic Damage – such as a tear
• Aortic Regurgitation – when some blood flows backwards into the heart instead of pumping it out of the heart
• Aortic Valve damage and/or functional impairment
• Arrhythmia – irregular heart beat
• Arteriovenous fistula – abnormal connection between the artery and a vein
• Aortoesophageal fistula – life threatening bleed due to an abnormal communication between the esophagus and the aorta
• Bleeding and Bleeding complications
• Cardiac Arrest – sudden sometimes temporary, stopping of the function of the heart
• Claudication (e.g. lower limb) – pain in your lower limbs due too little blood flow to the legs resulting
• Congestive heart failure – a chronic condition where the heart is not pumping as well as it should
• Coronary artery occlusion – partial or complete blockage of the coronary artery
• Coronary artery stenosis – narrowing of the coronary artery
• Dissection of a vessel - injury to inner layer of aorta allows blood to flow between the aortic layers
• Edema - abnormal collection of fluid
• Embolization (air, blood clot, tissue, etc.) the formation of a blood clot, air bubble, piece of fatty despot or other object which has been carried into the bloodstream to lodge in a vessel and cause an obstruction
• Emergency operation (e.g. surgical conversion to open repair)
• Endocarditis – and infection of the hearts inner lining
• Endoleak - blood leak through or around the device
• Fistual - abnormal opening
• Genitourinary complications (e.g. erosion) – complications of the urinary and genital organs
• Hematoma - localized bleeding outside of blood vessels
• Hematuria - presence of blood in the urine
• Hemorrhage, requiring blood transfusion – profuse escape of blood from a ruptured blood vessel
• Hemorrhagic pleural effusion – buildup of blood between the tissues that line the lungs and the chest
• Hepatic Failure – liver failure
• Hypertension - high blood pressure
• Hypotension – low blood pressure
• Ileus - lack of moment that leads to a buildup
• Impotence – inability to achieve an erection or have an orgasm
• Incontinence – inability to control urination
• Infarction – obstruction of the blood supply to an organ or region of tissue, often an embolus or thrombus, causing local death of the tissue
• Infection – invasion and multiplication of microorganisms such as bacteria that are not normally present within the body.
• Inflammation (localized or general) – swelling of part of the body
• Ischemia transient or permanent – reduced blood flow
• Lymphatic complications, such as lymphocele which is a collection of lymphatic fluid in the body not bordered by epithelial lining.
• Multiple organ failure syndrome – when more than one organ fails
• Myocardial infarction - heart attack
• Myocardial perforation – puncture of the heart
• Necrosis - tissue death
• Neurologic complications such as lipothymy (fainting) or encephalopathy brain disease that alters brain function
• Obstruction/Occlusion - no movement or blockage
• Paralysis including vocal cords and diaphragm – immobilization of one or more parts of the body
• Paraparesis - partial paralysis of both legs
• Paraplegia - paralysis of the legs and lower part of the body
• Pericardial tamponade – when fluid in the pericardium (the sac around the heart) builds up resulting in the compression of the heart
• Perforation of a vessel wall - hole made by piercing
• Peritonitis - inflammation of the tissue that lines the inner wall of the abdomen
• Pseudoaneurysm - collection of blood that forms between the two outer layers of an artery
• Pulmonary complications and subsequent attendant problems – complications pertaining to lungs
• Renal insufficiency/failure – a condition in which the kidney loses the ability to remove waste and balance fluids
• Rupture of a vessel - break or burst of the aorta
• Sepsis – chemicals released in the bloodstream to fight an infection but trigger inflammation throughout the body.
• Seroma – collection of fluids that build up under your skin.
• Stroke - decreased blood flow to the brain causing brain cells death
• Syncope – fainting or temporary loss of consciousness
• Temporary neurological deficit – abnormal function of a body area temporarily
• Thrombosis - formation of a blood clot
• Transient ischemic attack – temporary blockage of blood flow to the brain, often called a “mini stroke”
• Vascular spasm or vascular trauma – sudden brief tightening of a blood vessel that can block blood or injury to the blood vessel
• Ventricular fibrillation – rapid inadequate heartbeat
• Ventricular tachycardia – when the lower chambers of the heart (ventricles) beat very fast
• Vessel damage – injury to vessel
• Wound complications – often causes delay in healing including when the edges of the wound no longer meet (dehiscence) or a bacterial skin infection (cellulitis).
In addition to the aforementioned adverse events, several stent graft complications may occur. Including but not limited to: improper placement; incomplete deployment; inadequate apposition, migration; graft twisting or kinking; wear; dilatation; erosion; collapse of the component; breakage of the device suture or stent; insertion and removal difficulties; puncture and perigraft flow (flow outside of the graft lumen). There may be other potential risks that are unforeseen at this time. The occurrence of the above listed risks may lead to the need for a repeat procedure, emergency surgery, or death. Your study doctor has more detailed information on the risks of treatment with the NEXUS™ Aortic Arch Stent Graft System, including a complete list of warning, precautions and potential Side Effects/Adverse Events (AEs). You should talk to your study doctor about any side effects or allergic reactions that you have while taking part in the study.
What if I join the study and decide I do not want to participate anymore?
You may decide to stop participating in this study at any time. If you decide to withdraw from this clinical research study, you will be asked to participate in a limited capacity allowing your medical status to be followed by telephone contact, medical chart review, or by other agreed upon methods. If you decide not to continue participation in a limited capacity, your study doctor will not access your medical record or other confidential records for new purposes related to the study; however, study data collected prior to your withdrawal may be reviewed and publicly available records may be consulted prior to or after you withdraw. If you decide to stop taking part in this clinical research study, you must tell your study doctor as soon as you decide to stop. Regardless if you stay in the study or not and you received a study device, regular follow-up with a doctor, such as your primary care physician, for the rest of your life is important. Your doctor will want to make sure the study device is working properly even if you are not showing any symptoms.
How long does the study last?
It is estimated the entire study will take seven (7) years; however, your participation in the clinical research study will last about 60 months. You will need to visit the doctor’s office for study follow-up visits approximately seven (7) times over the course of the study.
What does the NEXUS™ device involve?
How many people can participate in the study?
Up to 100 patients will take part in this clinical research study at up to 30 different locations in the United States and up to one (1) location outside of the United States (New Zealand).
What are the benefits of participating in this study?
There are no guaranteed benefits from participation in this study. It is possible that after the NEXUS™ Aortic Arch Stent Graft System opens and expands to the final shape of the area above and below the diseased area of the aorta may help treat your condition, which may reduce the need for you to undergo further procedures but there are no guarantees. It is possible that by participating in this study your condition may improve or that this study may be helpful in developing a new therapy for others with similar illnesses. Even if you do not benefit directly from this research, knowledge gained from the study will contribute valuable information to researchers and doctors in the treatment of aortic arch disease and conditions.
How much will it cost?
You are responsible to pay for any items or services that are standard of care (that is, part of routine medical care) for your condition; and Endospan is charging for the NEXUS™ Aortic Arch Stent Graft System. To the extent you have insurance that pays for any routine medical care, you are responsible for any insurance copays and deductibles.