Zenith® t-Branch for Thoracoabdominal Aortic Aneurysms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Boca Raton Regional Hospital (BRRH), Boca Raton, FL
Thoracoabdominal Aortic Aneurysms+3 More
Zenith® t-Branch - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of stent may help treat aortic aneurysms.

See full description

Eligible Conditions

  • Thoracoabdominal Aortic Aneurysms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Thoracoabdominal Aortic Aneurysms

Study Objectives

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.

Day 30
Early Mortality
Day 31
Rates of Neurologic Complications/Late Branch Vessel Patency

Trial Safety

Safety Progress

1 of 3

Other trials for Thoracoabdominal Aortic Aneurysms

Trial Design

1 Treatment Group

Single Treatment Arm
1 of 1
Experimental Treatment

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.

Single Treatment Arm
Device
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0-day 30 (early) day 31-1825 (late)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 0-day 30 (early) day 31-1825 (late) for reporting.

Closest Location

Boca Raton Regional Hospital (BRRH) - Boca Raton, FL

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Additional criteria for LP material
Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or Penetrating ulcers: ≥20mm in depth or Chronic type B aortic dissections: ≥50mm total aortic diameter or Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Patient Q&A Section

What are common treatments for aneurysm?

"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

Unverified Answer

What are the signs of aneurysm?

"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

Unverified Answer

What causes aneurysm?

"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

Unverified Answer

How many people get aneurysm a year in the United States?

"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

Unverified Answer

Can aneurysm be cured?

"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

Unverified Answer

What is aneurysm?

"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

Unverified Answer

Has zenith® t-branch proven to be more effective than a placebo?

"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

Unverified Answer

What are the latest developments in zenith® t-branch for therapeutic use?

"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

Unverified Answer

How serious can aneurysm be?

"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

Unverified Answer

Who should consider clinical trials for aneurysm?

"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

Unverified Answer

Does zenith® t-branch improve quality of life for those with aneurysm?

"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

Unverified Answer

Have there been any new discoveries for treating aneurysm?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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