Endovascular Repair for Aortic Aneurysm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Age <18, Pregnancy, Life expectancy <2 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different stent devices in repairing aortic aneurysms, which are dangerous bulges in the body's main artery. It tests both custom-made and ready-made devices to determine which is more effective for various aortic issues, including those near the kidneys, chest, and arch of the aorta. Suitable candidates for this trial include individuals with large, growing, or saccular (sac-like) aortic aneurysms that standard devices cannot treat. The trial aims to enhance treatment options and safety for patients with these complex conditions. As an unphased trial, it offers patients the chance to contribute to research that could improve treatment options for complex aortic aneurysms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these devices are safe for endovascular repair of aortic aneurysms?

Research has shown that custom-made devices (CMDs) for repairing aortic aneurysms are generally well-tolerated. For the Fenestrated CMD group, early results indicate a 1-year survival rate of 92.3%, suggesting safety in complex aneurysm repairs. Evidence suggests these devices are a safe option for treating difficult abdominal aneurysms, with minimal side effects.

For the Type I-III thoracoabdominal aneurysm group, studies have shown promising results for ready-made branched devices. These devices can be used successfully even in emergencies, further supporting their safety for complex aneurysm repairs.

In the Arch group, repairing thoracic aortic aneurysms with these devices has yielded good results for patients with suitable anatomy. Studies report positive mid-term outcomes, indicating a strong safety record.

Overall, these devices have demonstrated a solid safety profile for different types of aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for aortic aneurysms because they offer a tailored approach to complex vascular issues. The Fenestrated CMD cohort uses a custom-made device to address specific aneurysm complexities like juxtarenal and suprarenal aneurysms, which aren't directly targeted by standard surgical or endovascular repairs. The Type I - III TAAA cohort employs innovative branched devices, offering off-the-shelf solutions for thoracoabdominal aneurysms, potentially increasing accessibility and reducing preparation time. Meanwhile, the Arch cohort provides patient-specific stent-grafts with inner branches, which might offer improved outcomes by accommodating unique anatomical needs. These approaches are promising because they aim to enhance precision and effectiveness compared to traditional, one-size-fits-all treatments.

What evidence suggests that this trial's treatments could be effective for aortic aneurysms?

This trial will evaluate different endovascular repair strategies for aortic aneurysms. Participants in the Fenestrated CMD cohort will receive custom-made devices with small openings. Studies have shown these devices effectively treat complex bulges in the abdominal aorta, especially near the kidneys and in the chest and abdomen. The Type I - III TAAA cohort will use ready-made devices with branches. Research indicates these devices are promising for certain chest and abdominal aorta bulges, performing well in both emergency and planned surgeries. For the Arch cohort, patients will receive stent-grafts tailored to them, which have shown good medium-term results in controlling the bulge's growth and improving patient outcomes. Overall, these treatments have demonstrated positive results in previous patients and clinical studies. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with specific types of aortic aneurysms (bulges in the wall of the artery) that are at risk of rupture and not suitable for standard treatment. Candidates must have anatomy compatible with custom-made or off-the-shelf stent-grafts, be able to follow up, and consent to participate. Pregnant individuals, those with recent procedures or participation in other trials, severe allergies to contrast material, certain infections or connective tissue disorders are excluded.

Inclusion Criteria

I cannot or will not give my consent to participate.

I have a blood clotting disorder that cannot be corrected.

Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

Exclusion Criteria

My aortic dissection does not meet the specific trial criteria.

My aortic arch condition does not meet the specific criteria mentioned.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair using fenestrated and branched devices for complex aortic aneurysms

12 months

Multiple visits for device implantation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits for monitoring adverse events and device integrity

Extension

Long-term monitoring of participants for major adverse events and device performance

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Arch cohort
• Endovascular Repair
• Fenestrated CMD
• Type I - III TAAA

Trial Overview The study tests endovascular repair devices on three groups: one using custom devices for juxtarenal/suprarenal/type IV thoracoabdominal aneurysms; another for type I-III thoracoabdominal aneurysms needing branched/fenestrated devices; and a third group treated with patient-specific stent-grafts for aortic arch aneurysms.

How Is the Trial Designed?

Group I: Type I - III TAAA cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.

Group II: Fenestrated CMD cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Group III: Arch cohort Experimental Treatment 1 Intervention

Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

The development of fenestrated and branched endovascular aneurysm repair (F-EVAR, B-EVAR) techniques allows for less invasive treatment options for complex aortic pathologies, which traditionally required more risky open surgeries.

Custom-made endografts tailored to individual patients' anatomy are becoming increasingly important, as they can improve outcomes for challenging cases like thoracoabdominal aortic aneurysms (TAAA), which are associated with high morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aortic Aneurysm: Fenestrated/Branched Endovascular Aortic Repair (EVAR) and Fenestrated/Branched Thoracic Endovascular Aortic Repair (TEVAR). Is Total Endovascular Repair Already Here?] Mehmedovic, A., Konstantinou, N., Jerkku, T., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35094747/

Endovascular stent grafting and open surgical replacement ... The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study aimed to investigate aneurysm growth rates, patient outcomes, quality of life and costs, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1078588422005068

Midterm Outcomes of Endovascular Repair of Aortic Arch ... This article describes the three year outcomes of a prospective observational study of a new single branch endograft for the repair of aortic arch aneurysms and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02089607

Complex Abdominal, TAAA, Aortic Arch Aneurysm or ... The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of ...

4. advradiology.org advradiology.org/articles/thoracic-endovascular-stent-graft-implantation-efficacy/AdvRadiolImaging.galenos.2024.47966

Thoracic Endovascular Stent Graft Implantation Efficacy In this study, we tried to present the treatment effectiveness and results of EVSG implantation using different stent-grafts in 34 patients with ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(17)30038-1/fulltext

Outcomes of thoracic endovascular aortic repair using ... This study represents the largest published experience of AAC stents with TEVAR for zone 0 and zone 1 deployments; it further supports the role of these ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3140248/

Endovascular Repair of Thoracic Aortic Aneurysms - PMC Endovascular repair of descending thoracic aortic aneurysms has outcomes that are favorable in patients with suitable anatomy.

7. jovs.amegroups.org jovs.amegroups.org/article/view/131607/html

Single-center retrospective cohort study on long-term ... This study provides long-term outcomes (up to 9.5 years) of Zone 1 aortic arch repair using the Frozenix Open Stent-Graft in a large cohort of 353 patients.

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/399601

Long-term Results of Endovascular Abdominal Aortic ... This study was performed to evaluate the long-term data of patients treated with the first generation of commercially available stent grafts.