TEVAR + Medication for Aortic Dissection

(IMPROVE-AD Trial)

Recruiting at 56 trial locations

Overseen By Jacqueline Huvane, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Systemic infection, Pregnancy, Genetic aortopathy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment TEVAR for aortic dissection?

Research shows that TEVAR (Thoracic Endovascular Aortic Repair) is beneficial for patients with complicated type B aortic dissection, offering better survival rates compared to open surgery or just medication. It is considered the best option for complicated cases, helping to improve the condition of the aorta (the main artery in the body). ^{1 2 3 4 5}

How is TEVAR treatment different for aortic dissection?

TEVAR (Thoracic Endovascular Aortic Repair) is unique because it involves placing a stent (a small mesh tube) inside the aorta through a minimally invasive procedure, which can help repair the damaged area without the need for open surgery. This approach is particularly beneficial for patients with complicated type B aortic dissection, as it promotes early positive changes in the aorta and can improve long-term outcomes. ^{1 4 6 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

Research Team

Manesh R Patel, M.D.

Principal Investigator

Duke University

Firas F Mussa, M.D.

Principal Investigator

The University of Texas at Houston

Panos Kougias, M.D.

Principal Investigator

The State University of New York at Downstate

Eligibility Criteria

This trial is for adults over 21 with a type B aortic dissection, which is a tear in the lower part of the major artery coming from the heart. It's not for tears at or near where blood vessels branch to the head and arms. Participants must be within 6 weeks of their initial hospital visit and able to follow study procedures.

Inclusion Criteria

I am older than 21 years.

My aortic dissection is in the part of the aorta far from my heart and has not caused organ damage or rupture.

I was admitted to the hospital for my condition between 2 days and 6 weeks ago.

Exclusion Criteria

Life expectancy related to non-aortic conditions < 2 years

I have had an aortic aneurysm before.

I have an aortic dissection caused by a medical procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Treatment

Participants are randomized to either upfront TEVAR plus medical therapy or medical therapy with surveillance for deterioration

6 weeks

Initial visit for randomization and treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment via centralized call center and remote blood pressure monitoring

4 years

Regular follow-up through remote monitoring and medical record review

Treatment Details

Interventions

• TEVAR

Trial Overview The trial tests if TEVAR (a minimally invasive surgery to repair the dissected aorta) combined with medical therapy works better than just medical therapy and watching patients closely for any worsening signs in treating uncomplicated type B aortic dissections.

Participant Groups

Group I: Upfront TEVAR plus Medical Therapy Experimental Treatment 2 Interventions

Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).

Group II: Medical Therapy with surveillance for deterioration Active Control 1 Intervention

Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

TEVAR is already approved in European Union, United States for the following indications:

Approved in European Union as TEVAR for:

• Type B aortic dissection
• Thoracic aortic aneurysms
• Aortic rupture
• Malperfusion syndrome

Approved in United States as TEVAR for:

• Acute complicated Type B aortic dissection
• Uncomplicated Type B aortic dissection
• Thoracic aortic aneurysms
• Aortic rupture
• Malperfusion syndrome

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

State University of New York - Downstate Medical Center

Collaborator

Trials

67

Recruited

12,100+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 140 patients with stable type B aortic dissection, those who underwent thoracic endovascular aortic repair (TEVAR) had significantly lower rates of aorta-specific mortality (6.9% vs. 19.3%) and disease progression (27.0% vs. 46.1%) compared to those receiving optimal medical treatment alone after 5 years.

TEVAR was associated with improved survival rates and reduced disease progression, particularly benefiting from stent graft-induced false lumen thrombosis in 90.6% of cases, suggesting that TEVAR should be considered for better long-term outcomes in suitable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Nienaber, CA., Kische, S., Rousseau, H., et al.[2022]

In a study of 132 patients undergoing thoracic endovascular aortic repair (TEVAR) for type B dissection, those who had the procedure delayed (between 14 days and 6 weeks) experienced fewer severe complications compared to those who had TEVAR within 48 hours or between 48 hours and 14 days after symptoms began.

Overall survival rates were similar across all timing groups, suggesting that while delaying intervention may reduce complications, it does not negatively impact survival outcomes for patients who are stable enough to wait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of timing on major complications after thoracic endovascular aortic repair for acute type B aortic dissection. Desai, ND., Gottret, JP., Szeto, WY., et al.[2022]

In a study of 108 patients undergoing thoracic endovascular aortic repair (TEVAR) for acute dissection, those with DeBakey extent IIIA dissection showed better aortic remodeling and a higher rate of false lumen thrombosis compared to those with extent IIIB dissection.

Despite differences in patient characteristics and aortic morphology, early and late outcomes (including survival rates) were similar between the two groups, suggesting that TEVAR is effective for both types of dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent Grafting Acute Aortic Dissection: Comparison of DeBakey Extent IIIA Versus IIIB. Arafat, A., Roselli, EE., Idrees, JJ., et al.[2022]

In a study of 90 patients undergoing thoracic endovascular aortic repair (TEVAR) for aortic dissection, technical success was achieved in 100% of cases, highlighting the efficacy of this treatment method.

Despite the high success rate, the procedure carries a 5.5% mortality rate and significant morbidity, including respiratory failure in 28% of patients, indicating that while TEVAR improves outcomes for aortic dissection, it is not without risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic endovascular aortic repair for type B aortic dissection. Younes, HK., Harris, PW., Bismuth, J., et al.[2022]

TEVAR (Thoracic Endovascular Aortic Repair) for complicated acute type B aortic dissection shows low in-hospital (3.9%) and 1-year (5.8%) mortality rates, indicating it is a safe intervention for these patients.

The procedure effectively promotes complete thrombosis of the false lumen in most patients, particularly in DeBakey 3b cases, while also significantly increasing the volume of the true lumen, suggesting it is effective in managing the condition and preventing further complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortic Remodeling After Endovascular Repair of Complicated Acute Type B Aortic Dissection. Leshnower, BG., Duwayri, YM., Chen, EP., et al.[2022]

Elderly patients (80 years and older) with subacute type B aortic dissection showed excellent long-term outcomes with medical treatment, maintaining a high freedom from aorta-related death (97% at 5 years).

Although older patients had fewer surgical interventions compared to younger patients, the rates of aortic-related death were similar between both age groups, suggesting that medical management can be effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How should we treat uncomplicated subacute type B aortic dissection in octogenarians? Nakamura, K., Uchida, T., Hamasaki, A., et al.[2022]

In a case of complicated acute type B dissection, the endograft was mistakenly deployed in the false lumen, highlighting the importance of careful insertion techniques during thoracic endovascular aortic repair (TEVAR).

When this complication occurred, it was successfully managed by replacing the entire aorta under deep circulatory arrest, emphasizing the need for a well-defined protocol and readiness for surgical conversion in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular graft deployment in the false lumen of type B dissection. Follis, F., Filippone, G., Stabile, A., et al.[2022]

In a study of 31 patients treated with thoracic endovascular aortic repair (TEVAR) for acute complicated type B aortic dissection, 84% achieved complete obliteration of the false lumen in the stented segment, indicating effective long-term remodeling.

However, the study also found that without obliteration of the false lumen beyond the stented area, there is a risk of aneurysmal degeneration in the distal aorta, highlighting the need for ongoing monitoring and potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late aortic remodeling persists in the stented segment after endovascular repair of acute complicated type B aortic dissection. Conrad, MF., Carvalho, S., Ergul, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of timing on major complications after thoracic endovascular aortic repair for acute type B aortic dissection. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Stent Grafting Acute Aortic Dissection: Comparison of DeBakey Extent IIIA Versus IIIB. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Thoracic endovascular aortic repair for type B aortic dissection. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Aortic Remodeling After Endovascular Repair of Complicated Acute Type B Aortic Dissection. [2022]

6. England pubmed.ncbi.nlm.nih.gov

How should we treat uncomplicated subacute type B aortic dissection in octogenarians? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Endovascular graft deployment in the false lumen of type B dissection. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Late aortic remodeling persists in the stented segment after endovascular repair of acute complicated type B aortic dissection. [2022]