This trial is evaluating whether Zenith® t-Branch will improve 1 primary outcome and 1 secondary outcome in patients with Thoracoabdominal Aortic Aneurysms. Measurement will happen over the course of 30 days post implant of the branch endografts.
This trial requires 225 total participants across 1 different treatment group
This trial involves a single treatment. Zenith® T-Branch 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.
"Most endovascular aneurysm and arteriovenous fistula procedures are performed using local or regional anesthesia. Local anesthesia is used to treat and preserve the patency of the blood vessel and the avoidance of hemorrhage during a procedure. Local anesthetic solutions contain epinephrine because adrenaline is widely considered to be pro-inflammatory. However, a few centers now use local anesthesia which does not contain systemic epinephrine. Systemic epinephrine is used to decrease heart rate. A high heart rate causes increased cardiac output which is not necessary to survive an attack of tachycardia. The anesthetic may induce other systemic effects of epinephrine if administered for too long." - Anonymous Online Contributor
"Abdominal pain, sudden changes in bowel patterns and vomiting are the main signs of aortic aneurysm. Patients who develop one of these symptoms need to be brought to the attention of a doctor immediately." - Anonymous Online Contributor
"This is the largest case-control study of the relative importance of risk factors for VUR. The findings support the hypothesis that smoking predisposes to aneurysm as well as to the occurrence of VUR in non-smoking subjects. Smoking was the factor conferring the greatest risk for intracranial aneurysm in this study." - Anonymous Online Contributor
"The incidence of AAA in the United States is approximately 4.3 per 100,000 persons per year. Most AAA are asymptomatic and do not require treatment. AAA is more frequently diagnosed in African-American men than in white men, particularly in those aged 65 years or older. Copyright © 2016 John Wiley & Sons, Ltd." - Anonymous Online Contributor
"In the modern era, a large number of patients with symptomatic intracranial aneurysms will die before therapeutic intervention because the risk-benefit ratio does not favor intervention. Survival rates obtained with surgery or medical treatment appear similar, and patients should be informed appropriately prior to treatment." - Anonymous Online Contributor
"Aneurysms are lesions in the wall of an artery with abnormal and dilation that causes blood to be retained or is not pumped appropriately out. This may occur as a result of weakened or narrowed arteries, or may occur spontaneously or due to a ruptured plaque. Many common, benign conditions develop into aneurysms, but aneurysms are a major cause of deaths in the United States and, therefore, deserve recognition." - Anonymous Online Contributor
"On September 28, 2012, a Zenith® t-branch implant by GE Healthcare was approved in the United States and Canada of the first drug-eluting bifurcated aortic prosthetic valve (t-MMA) that has been shown to provide superior early and late clinical, safety, and performance related outcomes. Additional data regarding long-term outcomes of the t-MMA Zenith® TAVI system, which includes a second drug-eluting valve (semi-rigid), is provided in the forthcoming GE Healthcare Zenith® TAVI 2 and 3 reports. These reports are expected to become available by April 2013." - Anonymous Online Contributor
"The Zenith(®) t branch system is a versatile platform for the deployment of a variety of therapeutic agents in coronary and peripheral sites. Zenith(®) t branches may represent a powerful therapeutic tool for the treatment of restenosis and target tissue regeneration after angioplasty with or without drug-eluting stents." - Anonymous Online Contributor
"Aneurysms of the abdominal aorta in men are extremely infrequent but extremely deadly (8% death within 1 year among a group of men with known and suspected aneurysms) and should be considered when any abdominal aortic aneurysm is suspected. The mortality is greatest if the aneurysm ruptures. Aneurysms of the abdominal aorta are also responsible for over 1% of deaths in women, but the absolute mortality rate is considerably lower than that in men. This suggests that the management of aneurysms of the abdominal aorta must be gender specific." - Anonymous Online Contributor
"Patients aged <60 years have the highest rate of AAA rupture and require surgery, the highest risk of death or major amputation, higher morbidity, and higher healthcare costs regardless of the type of aneurysm. Aneurysms are primarily of arteriosclerotic origin and treatment strategies involve [medial|medial]] endovascular aneurysm repair; most patients have excellent outcomes with low recurrence rates. Patients aged 40 to 60 are at high risk for thrombosis. Randomized controlled studies are indicated." - Anonymous Online Contributor
"While there was a trend towards improvement in QoL as a consequence of ZT-branch usage, there was no statistical difference. Patient comfort should guide treatment options for managing symptomatic aortic aneurysms." - Anonymous Online Contributor
"The aneurysm of both saccular (intracranial) and extracranial aneurysms have been studied and treated by surgery, embolization, and angioscopy in an animal model. However, no one technique has been definitively proven to be superior. Moreover, embolization and angioscopy can be very difficult in human medicine." - Anonymous Online Contributor