Subjects who receive the Treovance stent-graft for Aneurysm

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Rochester -- Strong Memorial Hospital, Rochester, NY
Aneurysm+3 More
Subjects who receive the Treovance stent-graft - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a stent-graft can be used to treat abdominal aortic aneurysms.

See full description

Eligible Conditions

  • Aneurysm
  • Abdominal Aortic Aneurysms (AAA)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Subjects who receive the Treovance stent-graft will improve 2 primary outcomes and 3 secondary outcomes in patients with Aneurysm. Measurement will happen over the course of 30 days.

12 months
Primary Efficacy
30 days
Primary Safety
Month 12
Secondary Safety Endpoint
Month 6
Secondary Efficacy Endpoint -- Device-Related Complications
Month 6
Secondary Efficacy Endpoint-- Secondary interventions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treovance
1 of 1
Experimental Treatment

This trial requires 150 total participants across 1 different treatment group

This trial involves a single treatment. Subjects Who Receive The Treovance Stent-graft is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treovance
Device
Subjects who receive the Treovance stent-graft

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

University of Rochester -- Strong Memorial Hospital - Rochester, NY

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:
Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months

Patient Q&A Section

Can aortic aneurysm, abdominal be cured?

"AA, abdominal aneurysm, is a devastating disease. The mortality is less than 10% in most countries, and can be prevented by early detection, adequate treatment, and early intervention." - Anonymous Online Contributor

Unverified Answer

What is aortic aneurysm, abdominal?

"In most of the population, aortic aneurysm is associated with abdominal aortic aneurysm. Although many individuals have abdominal aortic aneurysms, many abdominal aortic aneurysms are asymptomatic. In most people, the presence of an abdominal aortic aneurysm causes no symptoms or signs. In a subgroup of patients, surgical repair is the only option. Although surgery is often offered as a treatment option, other alternatives are available. There is little evidence to prove that a conservative approach that avoids surgery is preferable. The goal of treatment is prevention of worsening of symptoms." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic aneurysm, abdominal?

"Findings from a recent study supports the notion that one-third of people with aortic aneurysm are asymptomatic but those with symptomatic aneurysm more frequently have concomitant abdominal symptoms such as abdominal pain or fullness." - Anonymous Online Contributor

Unverified Answer

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

"More than 300 people per year die from abdominal aortic aneurysms. The average lifetime risk for abdominal aortic aneurysms is 20 per cent. There is a gender difference in disease occurrence with the women having a 10 to 30 percent higher odds of developing an abdominal aortic aneurysm. Most of the abdominal aortic aneurysms will not result in death while the mortality rate of ruptured aneurysms is high. In the United States, the average age of death from ruptured aneurysms is 73, with around half the people living to 90 years old. The life expectancy for males is 81 years old while that for females is 82 years." - Anonymous Online Contributor

Unverified Answer

What causes aortic aneurysm, abdominal?

"The cause of aortic aneurysms appears to be complex, with environmental, genetic, vascular, and immunologic factors being all likely to play a role in aortic aneurysm disease. In most cases these factors act in concert to promote aortic aneurysm formation and progression. However, the mechanisms or pathways by which these factors act are not yet known, and many of these factors may prove to be modifiable or controllable." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic aneurysm, abdominal?

"There is no cure for aortic aneurysm, and no treatment to prevent complications after rupture. Treatments include endovascular repair, open surgery and transarterial embolization. Treatment of abdominal aortic aneurysm is very important." - Anonymous Online Contributor

Unverified Answer

What is subjects who receive the treovance stent-graft?

"[With treovance, we found only 2 subjects with aortic dissection and 2 subjects with type III thoracic aortic dissection, so we think the application of the treovance stent-graft in our patients who suffer aortic dissection would not be reasonable(https://transcranial.aiphost.org/public/diseases/aortic-dissection/diagnosis/aortic-dissection.aspx).] Most participants of the treovance stent-graft studies who have the aortic dissection are from Europe and their ethnicity is usually Caucasian." - Anonymous Online Contributor

Unverified Answer

Is subjects who receive the treovance stent-graft typically used in combination with any other treatments?

"Inclusion of any type of treatment as a "add-on" after endovascular treatment of AAA is not common. This may be partly explained by the low incidence of any residual AAA following EVAR." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving subjects who receive the treovance stent-graft?

"We did not detect significant clinical benefit in this study involving a relatively small number of subjects. However, additional study with a larger number of patients is warranted." - Anonymous Online Contributor

Unverified Answer

How does subjects who receive the treovance stent-graft work?

"Subjects treated with the Treovance stent-graft show no difference in symptom scores, renal function, or imaging studies with respect to patency, aortic enlargement, or aortic dissection." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aortic aneurysm, abdominal?

"Patients with AA who present for screening in an asymptomatic status generally exhibit abdominal aortic aneurysms and rupture below the age of 65, but the mean age has declined from 67 in 2000 to 64 in 2005 (p = 0.0001). The proportion of patients below the current guideline for screening at age 65 years fell from 34% in 2000 to 13% in 2005. Most patients below age 65 years should be considered for AAA screening at the time they present for evaluation, rather than the current guideline of screening every 5 years. This trend could represent an overall decline in the prevalence of AA and/or a shift in the age-time distribution of AA presentations." - Anonymous Online Contributor

Unverified Answer

How serious can aortic aneurysm, abdominal be?

"The rate of rupture in symptomatic thoracic aortic aneurysms is about 4%. Rupture usually occurs at the proximal aneurysm sac (85%) and may be the result of endoleak. Rupture is most frequently a result of embolization of the proximal aortic neck that results in a distal embolization causing a focal aneurysm sac. Distal embolization can be a result of prosthetic grafts or aortic grafts, but is most often from other procedures." - 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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