Valiant Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Thoracoabdominal Aortic Aneurysms+3 More
Valiant Thoracoabdominal Stent Graft System - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a device can be used to repair 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 Valiant Thoracoabdominal Stent Graft System will improve 2 primary outcomes and 2 secondary outcomes in patients with Thoracoabdominal Aortic Aneurysms. Measurement will happen over the course of 30 Days post- procedure.

1- year post-procedure
Preliminary Effectiveness (treatment and technical success)
30 Days post- procedure
Freedom from MAEs (at 30 Days)
at each follow-up interval (five years)
Technical Success
Treatment Success

Trial Safety

Safety Progress

1 of 3

Other trials for Thoracoabdominal Aortic Aneurysms

Trial Design

2 Treatment Groups

Primary Study Arm
1 of 2
Expanded Use Arm
1 of 2
Experimental Treatment

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Valiant Thoracoabdominal Stent Graft System is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Primary Study Arm
Device
The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Expanded Use Arm
Device
The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. The expanded use arm provides broaden inclusion criteria to include select patients excluded from the primary study arm.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at each follow-up interval (five years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at each follow-up interval (five years) for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
Aneurysm with a history of growth > 0.5 cm in 6 months
Saccular aneurysm deemed at significant risk for rupture
Symptomatic aneurysm greater than or equal to 4.5 cm
Other inclusion criteria
Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) and a diameter in the range of 26-42 mm
Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
Age: ≥ 18 years old

Patient Q&A Section

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

"Endothelial degeneration of the aorta is estimated to occur in 17% of men and 11% of women; therefore, the total percentage of patients with an aortic aneurysm or other atherosclerotic disease is about 20% in the US. However, it has been reported that the prevalence and incidence of aneurysm are increasing. The prevalence of this disease is also increasing in the United States due to age-related factors and is estimated to be the third leading cause of death in males over 50 years. It has been shown that the prevalence and incidence of aneurysm are increasing in both males and in females over both 50 years and 100 years of age." - Anonymous Online Contributor

Unverified Answer

What causes aortic aneurysm?

"The disease is one that causes death in a small proportion of patients, but a very large proportion may avoid it with early detection and surgical correction. Many are diagnosed and treated too late when their disease is in critical phase." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic aneurysm?

"The common treatments for aortic aneurysms are listed below: \n- Surgery: aortic aneurysms can usually be surgically treated; however, there are risks to the patient.\n- Non-surgical: people with aortic aneurysms were commonly treated with anti-hypertensive medicines combined with beta blockers; this is no longer being recommended since it is ineffective. Also, other non-surgical treatment options that can be used include an aortic dissection medication and transcatheter therapy." - Anonymous Online Contributor

Unverified Answer

What is aortic aneurysm?

"Aortic aneurysm involves any of the parts of the aorta. Aortic aneurysm is a disease of the aorta characterized by its expansion and, therefore, enlargement. Aortic aneurysm is the third most common form of aortic pathology. It affects about 9% of people who are thought to be healthy in the United States. The first step in diagnosing an aneurysm is a physical examination. Other steps will be discussed in the text." - Anonymous Online Contributor

Unverified Answer

Can aortic aneurysm be cured?

"Aortic aneurysm is a common disease that has many different causes. Aortic aneurysms represent an unacceptably high risk. No evidence exists that current methods of screening and treatment of this disease have increased survival rates. In any event, aneurysms cannot be cured or prevented." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic aneurysm?

"Some of the signs of an aortic aneurysm include abdominal complaints, a pulsatile abdominal mass, hemoptysis, and decreased range of motion in extremities. Decreased aortic pulse pressure is an indicator of impending vascular patency deterioration. Finally, aortic height, aortic root diameter in cm, and aneurysm diameter in cm are useful for predicting an impending rupture, and aiding in the selection of the most appropriate approach." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in valiant thoracoabdominal stent graft system for therapeutic use?

"The Valiant Thoraco-Abdominal Stent Graft System has proven to be safe in the management of descending pathology, i.e. malignant compression of the descending aorta, and thoracic pathology." - Anonymous Online Contributor

Unverified Answer

Has valiant thoracoabdominal stent graft system proven to be more effective than a placebo?

"When performing EVAR, the use of the thoracoabdominal stent graft system was significantly better at preventing the development of ISR and the need for intervention than a placebo, and this conclusion was also seen in patients who were not eligible for EVAR." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of aortic aneurysm?

"Among the most respected and widely held guidelines for the diagnosis of AAA is the AAD as well as the British Thoracic Society. It is a fact that some people do not fit the typical case of rupture, that is, AAAs develop spontaneously without any history of trauma, a history of aortic aneurysms have only been reported in the past 20 years. AAAs appear to arise out of a complex interplay of biochemical and immunological stimuli, and it is likely that an immunological (endotoxin-antigen-induced) mechanism is involved in the formation of AAAs in some patients." - Anonymous Online Contributor

Unverified Answer

How does valiant thoracoabdominal stent graft system work?

"Patients who survived to discharge displayed low rates of late anastomotic leaks following primary visceral repair of AAA. There was a trend toward a lower rate of late anastomotic leaks among patients who did not undergo a TAGS procedure." - Anonymous Online Contributor

Unverified Answer

What does valiant thoracoabdominal stent graft system usually treat?

"The valiant thoracoabdominal stent graft system, although effective in restoring the thoracic aortic anatomy, may not prevent aortic aneurysm formation. Results from a recent clinical trial depend on the patient's initial aortic dimensions. A vigilant poststent surveillance is highly prudent to avoid an enlargement of the aortic aneurysms." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aortic aneurysm?

"The average age a person undergoes aortic aneurysm surgery is 67 and a half years of age. "

"Pallini\n\nPallini is a small Tuscan town in the province of Grosseto, Tuscany, Italy, in the subregion of Macchia." - 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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