TEVAR + Medication for Aortic Dissection

(IMPROVE-AD Trial)

Recruiting at 51 trial locations

Overseen By Kady-Ann Steen-Burrell, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two strategies for individuals with type B aortic dissection. One group will undergo a procedure called TEVAR (Thoracic Endovascular Aortic Repair), which involves placing a stent in the aorta, along with medication. The other group will receive medication and undergo close monitoring for any worsening of their condition. The trial aims to determine if performing the TEVAR procedure upfront is more effective at reducing death or major aortic complications compared to medication alone. Suitable participants have recently experienced an uncomplicated type B aortic dissection and are within a few weeks of their initial hospital admission. As an unphased trial, this study provides patients the chance to contribute to significant research that could enhance future treatment strategies.

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 TEVAR is safe for aortic dissection?

Research has shown that TEVAR, when combined with medical treatment, is generally well-tolerated. Studies indicate that TEVAR can lead to excellent results with few complications. For example, one study found that individuals who underwent TEVAR had an 83% chance of surviving for 10 years and a 92.3% chance of surviving without aortic-related issues. This suggests that TEVAR is relatively safe for treating uncomplicated type B aortic dissections.

Regarding side effects, another study reported low death rates for patients treated with TEVAR compared to other methods. However, it is important to understand that every medical treatment carries risks. The evidence so far shows that TEVAR is a promising option with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard approach, which primarily involves medical management with medications to control blood pressure and reduce cardiovascular risk, the treatment being explored combines TEVAR (Thoracic Endovascular Aortic Repair) with medical therapy. TEVAR is unique because it involves using a customized stent-graft device tailored to each patient's anatomy to reinforce the aorta from the inside, potentially offering more immediate structural support and preventing further aortic dissection. Researchers are excited about this approach because it might provide a more direct and effective intervention for stabilizing the aorta, especially in patients at high risk of deterioration, compared to relying solely on medication and surveillance.

What evidence suggests that TEVAR plus medical therapy could be effective for aortic dissection?

This trial will compare two treatment approaches for type B aortic dissection. One group of participants will receive thoracic endovascular aortic repair (TEVAR) combined with medical therapy. Research has shown that this combination can be effective, often resulting in lower death rates compared to using only medical treatment. TEVAR works well for patients with complications like a tear or severe pain, and patients usually experience few complications and have good long-term survival. The other group will receive medical therapy with surveillance for deterioration, following routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction. Overall, TEVAR plus medical treatment offers a promising way to manage type B aortic dissection. ^{5 6 7 8 9}

Who Is on the Research Team?

Sean O'Brien, Ph.D.

Principal Investigator

Duke University

Sreekanth Vemulapalli, M.D.

Principal Investigator

Duke University

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38157994/

Outcomes of thoracic endovascular aortic repair with ...

The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality. Keywords: Aortic arch pathologies; Partial ...

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ahajournals.org

ahajournals.org/doi/10.1161/JAHA.122.027641

Association of Thoracic Aortic Aneurysm Versus ...

The present study finds outcomes after TEVAR vary significantly based on aortic disease. Patients presenting with type B aortic dissection ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0741521417323637

Outcomes of thoracic endovascular aortic repair for chronic ...

In the setting of acute complicated type B aortic dissection, TEVAR has shown favorable outcomes for patients with malperfusion, rupture, chest pain, and aortic ...

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bmcsurg.biomedcentral.com

bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02555-4

Efficacy of thoracic endovascular aortic repair versus medical ...

Our meta-analysis revealed a significant association between the TEVAR group and a decreased mortality rate of TBAD compared to the medical treatment group.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36690933/

Long-term outcomes of thoracic endovascular aortic repair ...

The overall 10-years survival rate was 83% (6 of 48), and the aortic-related survival rate was 92.3% (3 of 48). Conclusions: TEVAR is a safe and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39336937/

Thoracic Endovascular Aortic Repair and ...

This study investigated the management and outcomes of TEVAR and EVAR as alternatives to traditional open surgical repair for managing aortic pathologies.

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frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1442800/full

Safe and favorable prognosis of thoracic endovascular ...

Short-and long-term outcomes of TEVAR for uncomplicated TBAD with a small aortic aneurysm were excellent, with few postoperative complications.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2589004223024367

Long-term survival of TEVAR for Type B aortic dissection

The mortality rates in the TEVAR and OMT groups were 17.16% and 36.17%, respectively, when the length of aortic dissection was >150 mm (p < 0.05) ...

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jvascsurg.org

jvascsurg.org/article/S0741-5214(22)02735-5/fulltext

Timing of TEVAR in Uncomplicated Type B Aortic Dissection

Timing of endovascular repair impacts long-term outcomes of uncomplicated acute type B aortic dissection. J Vasc Surg. 2022; 75:851-860.e3.