B-TEVAR Device for Aortic Aneurysm

(B-TEVAR Trial)

Overseen By Sandra Mata-Diaz, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Systemic infection, Mycotic aneurysm, Unstable angina, 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

Duration: 4-8 weeks

290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the B-TEVAR (Branched Thoracic Endovascular Grafts) for treating thoraco-abdominal aortic aneurysms, which are serious bulges in a major artery supplying blood from the heart to the body. Researchers aim to determine if this device can safely and effectively assist patients at high risk for traditional surgery due to other health issues. The trial focuses on using special stents (tiny tubes) to maintain blood flow to important arteries branching from the aneurysm. Suitable candidates have a large aneurysm (over 5.5 cm), or one that is growing quickly or causing symptoms. As an unphased trial, this study allows patients to contribute to innovative research that may lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have an absolute contraindication to anticoagulation (blood thinners), you cannot participate in the trial.

What prior data suggests that the B-TEVAR device is safe for treating thoraco-abdominal aortic aneurysms?

Research has shown that the B-TEVAR device, used for certain aortic aneurysms, offers promising safety results. In one study, the device functioned as intended in 94.4% of cases. However, 11.9% of patients experienced side effects, such as device movement or other complications.

Studies have found that thoracic endovascular aortic repair (TEVAR) is generally well-tolerated and considered a less invasive option for treating aortic issues, usually involving fewer risks than more invasive surgeries.

Although the FDA has not approved the B-TEVAR device, these studies provide some reassurance about its safety in humans. Discussing potential risks and benefits with healthcare providers is important before deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the B-TEVAR device for treating aortic aneurysms because it offers a minimally invasive alternative to traditional open surgery. Unlike standard treatments that involve large incisions and prolonged recovery times, the B-TEVAR device is implanted via a catheter through a small incision, which can lead to faster recovery and reduced complications. Additionally, it features advanced materials designed to better conform to the aorta's shape, providing a more secure and durable repair of the aneurysm. This innovative approach could significantly improve patient outcomes and quality of life.

What evidence suggests that the B-TEVAR device is effective for treating thoraco-abdominal aortic aneurysms?

Research has shown that special endovascular grafts, such as the B-TEVAR device studied in this trial, hold promise for treating thoraco-abdominal aortic aneurysms. One study found successful use of these devices in 94.4% of cases, indicating they are often placed and function correctly. Another study found that these devices can help reduce aneurysm-related deaths. The procedure is typically straightforward with few complications. These findings suggest that the B-TEVAR device could be a suitable option for patients unable to undergo open surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Matthew Sweet, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Adults over 18 with thoraco-abdominal aortic aneurysms needing branch vessel preservation, who are not pregnant and have a life expectancy over 1 year. Candidates must be at high risk for open surgery due to other health issues and agree to follow-up exams. Exclusions include active infections, certain allergies, unmanageable contrast media hypersensitivity, unstable angina, or participation in another trial.

Inclusion Criteria

Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

The patient is expected to live for more than 1 year.

Patient must be willing to comply with all required follow-up exams

Exclusion Criteria

You are allergic to contrast dye and can't be treated before using it.

Patient is currently participating in another investigational device or drug clinical trial

I have worsening chest pain, including at rest or at night.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Deployment of branched and fenestrated-branched endovascular stent grafts to treat thoraco-abdominal aortic aneurysms

4-8 weeks

Multiple visits for procedure and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• B-TEVAR device

Trial Overview The safety and effectiveness of Cook Medical's branched and fenestrated-branched endovascular stent grafts for preserving vital arteries in patients with thoraco-abdominal aortic aneurysms are being tested. This non-randomized study involves off-the-shelf and custom-made devices.

How Is the Trial Designed?

Group I: B -TEVAR Experimental Treatment 1 Intervention

Implantation of the B-TEVAR device

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

Approved in European Union as B-TEVAR device for:

• Thoraco-abdominal aortic aneurysms

Approved in United States as B-TEVAR device for:

• Used under Physician Sponsored IDE studies for thoraco-abdominal aortic aneurysms

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Branched endovascular arch repair (b-TEVAR) using custom-made double or triple-branched endografts was technically successful in 90% of cases for treating anastomotic aneurysms after open aortic surgery, indicating its efficacy as a treatment option.

The procedure showed a good safety profile, with all elective patients surviving and no early endograft-related re-interventions required, although two patients with urgent cases did not survive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular arch repair of anastomotic aneurysm and pseudoaneurysm in patients after open repair of the ascending aorta and aortic arch: a case series. Becker, D., Stana, J., Prendes, CF., et al.[2023]

Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) shows a high technical success rate of 95.9% in treating aortic arch conditions, based on a systematic review of 18 studies involving 571 patients.

The 30-day mortality rate after F/B-TEVAR is 6.7%, with no significant differences in outcomes between fenestrated and branched configurations, although fenestrated devices had a higher rate of type I-III endoleaks (9.8% vs. 2.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Fenestrated and Branched Endografts for Partial and Total Endovascular Repair of the Aortic Arch - A Systematic Review and Meta-Analysis. Spath, P., Campana, F., Tsilimparis, N., et al.[2023]

Surgeon-modified fenestrated thoracic endovascular aortic repair (TEVAR) is a promising approach for treating thoracic aortic aneurysms, allowing for extended landing zones without the need for open surgery, which can reduce operation time.

In a study of 29 cases using modified TEVAR techniques, complications associated with traditional debranch TEVAR, such as cerebral infarction and organ ischemia, were addressed, highlighting the potential for improved safety and efficacy in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgeon-modified Fenestrated Thoracic Endovascular Aortic Repair for the Treatment of Aortic Aneurysm]. Hashizume, K., Shimizu, H.[2017]

Fenestrated/branched thoracic endovascular aneurysm repair (F/Br-TEVAR) is an innovative minimally invasive treatment for post-dissection thoracoabdominal aortic aneurysms, particularly challenging when target vessels arise from the false lumen.

The study introduces a bailout technique using a TIPS-needle to perforate the dissection flap when standard catheterization fails, allowing for successful deployment of a bridging stent graft, enhancing the efficacy of F/Br-TEVAR in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Note: Dissection Flap Perforation with Use of a TIPS-Needle During Fenestrated Endografting for Post-dissection Thoracoabdominal Aneurysms. Mufty, H., Katsargyris, A., Houthoofd, S., et al.[2022]

Thoracic endovascular aortic repair (TEVAR) has become the preferred treatment for various thoracic aortic conditions, and the latest generation of TEVAR devices has improved upon earlier models by addressing limitations such as large delivery systems and graft migration.

Current TEVAR devices, including the GORE® TAG®, Medtronic Navion™, Bolton RELAY®, and Cook Zenith® Alpha™, feature advancements like adjustable deployment and low-profile systems, which enhance accuracy and broaden the range of treatable aortic pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic Aortic Endografts: Past, Present, and Future. Kumar, S., Choinski, KN., Tadros, RO.[2020]

TEVAR (Thoracic Endovascular Aortic Repair) has significantly improved patient outcomes for thoracic aortic conditions, showing reduced mortality and paraplegia rates compared to traditional open surgery.

Recent advancements in TEVAR techniques, such as chimney grafts and branched aortic devices, are expanding its application beyond the descending thoracic aorta, potentially enhancing treatment options for aortic arch disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Techniques in Thoracic Endovascular Aortic Repair: Chimneys/Periscopes, Fenestrated Endografts, and Branched Devices. Al-Hakim, R., Schenning, R.[2022]

The use of single branched endografts for treating zone II thoracic aortic lesions showed a high technical success rate of 94.86% and very low 30-day mortality (0.14%), indicating that this method is both safe and feasible for patients.

While the procedure demonstrated excellent unassisted left subclavian artery branch patency at 99.12%, there were notable rates of early type I endoleaks (5.19%) that may require further intervention, highlighting the need for ongoing monitoring and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Branched Endografts for the Preservation of Left Subclavian Artery in the Treatment of Zone II Thoracic Aortic Lesions a Systematic Review and Meta-Analysis. Bontinis, V., Bontinis, A., Chorti, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11494561/

Outcomes of thoracic endovascular aortic repair with ... Thoracic endovascular aortic repair (TEVAR) with fenestrated surgeon-modified stent-grafts (f-SMSGs) is becoming an option for treating type B aortic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01874197

Branched Thoracic Endovascular Grafts for the Treatment ... The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078588423006147

Outcomes of Fenestrated and Branched Endografts for ... Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) of the aortic arch is a viable approach in patients unsuitable for open repair.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38439540/

Outcomes of thoracic endovascular aortic repair using ... TEVAR with FSG is a simple procedure, with few complications. Additional treatment has been observed to reduce aneurysm-related deaths.

5. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00931-5/fulltext

Branched and fenestrated endovascular aortic arch repair ... Key Findings: Fenestrated and branched thoracic endovascular repair in 126 patients with native proximal aortic landing showed 94.4% technical success and 11.9% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884803/

Outcomes of thoracic endovascular aortic repair with ... Several studies reported promising outcomes after TEVAR with f-SMSGs for aortic arch pathologies, including type A/B aortic dissections, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4540616/

TEVAR: Endovascular Repair of the Thoracic Aorta - PMC The development of thoracic endovascular aortic repair (TEVAR) has allowed a minimally invasive approach for management of an array of thoracic aortic ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423021754

Early and midterm outcomes of fenestrated and branched ... A single-center retrospective analysis was conducted, including data from consecutive, elective and urgent (symptomatic and ruptured cases), ...