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

Trial Summary

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 data supports the effectiveness of the B-TEVAR device treatment for aortic aneurysm?

Research shows that advanced techniques in thoracic endovascular aortic repair (TEVAR), including the use of branched and fenestrated devices, have improved patient outcomes by reducing mortality and shortening hospital stays compared to traditional surgery. These techniques have been successfully used for various aortic conditions, suggesting potential effectiveness for aortic aneurysms as well. ^{1 2 3 4 5}

Is the B-TEVAR device generally safe for humans?

Research shows that the B-TEVAR device, used for repairing parts of the aorta (a major blood vessel), is a viable and minimally invasive option for patients who cannot undergo open surgery. Studies have investigated its safety and feasibility, indicating it is generally safe for treating various aortic conditions. ^{1 2 3 6 7}

How is the B-TEVAR device treatment different from other treatments for aortic aneurysm?

The B-TEVAR device is unique because it uses a minimally invasive approach with fenestrated and branched endovascular stent grafts, allowing for the repair of complex aortic aneurysms without the need for open surgery. This treatment is particularly beneficial for patients who are not suitable for traditional open repair, offering reduced recovery time and fewer complications. ^{1 2 3 4 5}

What is the purpose of this trial?

An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.

Research Team

Matthew Sweet, MD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

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

Technical Note: Dissection Flap Perforation with Use of a TIPS-Needle During Fenestrated Endografting for Post-dissection Thoracoabdominal Aneurysms. [2022]

3. Germany 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. [2023]

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

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

5. Japan pubmed.ncbi.nlm.nih.gov

[Surgeon-modified Fenestrated Thoracic Endovascular Aortic Repair for the Treatment of Aortic Aneurysm]. [2017]

6. Netherlands 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. [2023]

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

Thoracic Aortic Endografts: Past, Present, and Future. [2020]