ViTAA Analysis for Abdominal Aortic Aneurysm
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand and improve treatments for individuals with aortic aneurysms, which are dangerous bulges in the aorta, the main blood vessel. It will collect data on two groups: those undergoing endovascular repair (a less invasive surgery) and those whose aneurysms are being closely monitored but not yet treated. The focus is on using ViTAA's technology, a specialized analysis tool, to better track these patients' conditions. This trial is suitable for adults with an infrarenal aortic aneurysm (a bulge below the kidneys) that is at least 45 mm wide and who have not experienced certain other health issues, such as aortic dissection or kidney failure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those on oral or injected corticosteroids (except inhaled ones). It's best to discuss your specific medications with the trial team.
What prior data suggests that the ViTAA aortic mapping technology is safe for patients with aortic aneurysm disease?
Research shows that endovascular repair (EVAR) is generally well-tolerated for treating abdominal aortic aneurysms. Studies have found that EVAR carries a lower short-term risk compared to open surgeries. For instance, one study reported a 30-day death rate of about 2.9% for EVAR, which is lower than that of traditional surgeries.
Regarding long-term safety, another study demonstrated that EVAR effectively prevents aneurysm rupture and related deaths over many years. This suggests that patients typically do well after the procedure.
While no treatment is without risk, evidence indicates that endovascular repair has successfully improved outcomes and is considered a safer option than more invasive methods.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on improving how we monitor patients before and after endovascular aortic aneurysm repair (EVAR) and those under serial monitoring for abdominal aortic aneurysms (AAA). Unlike traditional practices that might only track immediate post-surgery outcomes, this trial emphasizes continuous monitoring to catch potential issues early and improve long-term results. By utilizing the ViTAA Analysis, researchers aim to gather detailed insights into patient progress and optimize care plans, potentially setting a new standard for managing these conditions. This approach could lead to more personalized and effective treatment plans for patients with aortic aneurysms.
What evidence suggests that ViTAA Analysis is effective for abdominal aortic aneurysm?
Studies have shown that endovascular repair (EVAR) is a safe and effective treatment for abdominal aortic aneurysm (AAA). Research indicates that EVAR carries a lower short-term risk of death compared to open surgery, with about 2.9% of patients experiencing this within 30 days. Long-term results are also positive, with approximately 52% of patients surviving five years after the procedure. In this trial, one group of patients will undergo EVAR, a reliable method that effectively prevents aneurysm rupture. These findings underscore its effectiveness in treating AAA, making it a dependable option for patients needing repair. Another group in this trial will include patients with infrarenal AAA who do not yet qualify for repair and will undergo serial monitoring.12467
Who Is on the Research Team?
Mark Farber
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Serial Monitoring
Patients with infrarenal AA without indications for repair are enrolled in a serial monitoring program
Pre and Post-Endovascular Repair
Patients scheduled for endovascular repair are monitored pre and post-procedure using ViTAA technology
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ViTAA Analysis
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program
Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViTAA Medical Solutions
Lead Sponsor
Citations
Long-term Outcomes After Endovascular Abdominal Aortic ...
Cumulative survival was 52% at 5 years. Conclusions: EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and ...
Temporal Trends and Outcomes of Abdominal Aortic ...
Low-risk patients increasingly underwent elective repairs (EVAR, +0.4%per year [95% CI, 0.2–0.6]; OAR, +0.6 points per year [95% CI, 0.2–1.0]).
Aortic Aneurysm Safety and Effectiveness of Open and ...
The pooled estimate of 30-day mortality for EVAR was 2.9% (95% confidence interval [CI]: 0.4–6.1%; I2 = 0%) and for OSR was slightly higher at 9% (95% CI: 5–15 ...
Outcomes of Endovascular Aneurysm Repair (EVAR) ...
The mortality rate for ruptured AAA after the endovascular repair was 24%, which was also lower than open repair of the ruptured AAA [6,9].
Outcomes in Elective Endovascular Aortic Repair vs Open ...
This study found no statistically significant difference between outcomes after EVAR and OSR to repair AAA in long-term mortality during more ...
Long-term Outcomes of Open vs Endovascular Abdominal ...
OAR was associated with a statistically significant increase in mortality at 1 year (389 deaths [9.0%] vs 2128 deaths [8.2%]; P = .02). Table 2.
Impact of an emergency endovascular aneurysm repair ...
The risk-adjusted 30-day mortality was 23.2% with the emergency EVAR protocol, versus 35.8% preprotocol (P = .0727). A subgroup analysis ...
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