B-SAFER Technique for Aortic Dissection

(B-SAFER Trial)

Overseen By Yuki Kuramochi, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eric Roselli, M. D.

Disqualifiers: Comatose, Severe brain malperfusion, Infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay (up to 1 month)

590 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of a new treatment called B-SAFER (Branched Stented Anastomosis Frozen Elephant Trunk Repair) for individuals with serious aortic problems. The focus is on repairing the thoracic aorta, a major artery in the chest that can develop issues such as aneurysms or dissections (tears). Participants must have a condition affecting multiple parts of their thoracic aorta that might require urgent repair. Ideal candidates have aortic conditions like a high-risk aneurysm or acute dissection needing immediate attention. Eligible participants should be able to give consent and have a life expectancy of more than two years after the repair. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future treatments for serious aortic conditions.

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 team or your doctor.

What prior data suggests that the B-SAFER technique is safe for aortic dissection?

Research has shown that the B-SAFER method for replacing part of the aorta is safe. Studies involving 178 patients with various aortic problems demonstrated good results. This procedure is described as safe and reliable, allowing for repeated positive outcomes. Early results from another study also highlight its wide applicability and high safety. These studies reported no major safety issues, suggesting that patients generally tolerate the B-SAFER technique well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The B-SAFER technique for aortic dissection is unique because it involves the use of a physician-modified endovascular stentgraft to treat the proximal aorta. Unlike traditional surgical options like open-heart surgery or conventional stenting, this approach allows for a more customized fit to the patient's aortic anatomy, potentially improving outcomes. Researchers are excited about this technique because it could offer a less invasive option with quicker recovery times and reduced risk of complications, making it a promising advance for patients with complex aortic disease.

What evidence suggests that the B-SAFER technique is effective for aortic dissection?

Research shows that the B-SAFER technique, which participants in this trial will receive, offers a promising way to repair the aortic arch, a crucial part of the body's main artery. Studies on patients needing complex heart surgery have found that this method is safe and can be successfully performed by different surgeons. The B-SAFER approach uses a special stent, a small mesh tube, to support the blood vessel and is designed to treat several parts of the aorta simultaneously. Early results suggest that this method effectively addresses total arch replacement, a challenging surgery. Overall, the B-SAFER technique has proven widely applicable and very safe for patients with conditions affecting the thoracic aorta. ^{1 3 4 6 7}

Who Is on the Research Team?

Eric Roselli, M. D.

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a life expectancy of more than two years who need repair or replacement of the thoracic aorta due to conditions like aneurysms, dissections, or congenital diseases. Participants must be able to consent and not have device sensitivities, uncorrectable bleeding disorders, active infections that could affect surgery outcomes, involvement in other studies with investigational products within the last six months, medical issues affecting trial participation, pregnancy, or severe brain malperfusion.

Inclusion Criteria

I need surgery for a serious problem with the main artery in my chest.

Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study

You are expected to live for at least two years after the treatment.

Exclusion Criteria

I cannot undergo major surgery that stops my blood circulation.

I am not in a coma or have severe, untreatable brain damage.

Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of a physician-modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments

Hospital stay (up to 1 month)

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of device functionality and monitoring for adverse events

36 months

Regular follow-up visits with CT imaging assessments

What Are the Treatments Tested in This Trial?

Interventions

• B-SAFER

Trial Overview The B-SAFER clinical trial tests a new hybrid surgical technique for repairing complex thoracic aortic pathologies. It's designed for patients requiring repair near the arch proximal to the innominate artery origin. This single-center study is prospective (looking forward in time), non-blind (patients and researchers know what treatment is given), and non-randomized (patients are not chosen by chance for different treatments).

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.

B-SAFER is already approved in United States for the following indications:

Approved in United States as B-SAFER for:

• Acute Aortic Dissection
• Chronic Aortic Dissection
• Degenerative Aortic Aneurysm
• Congenital Aortic Arch Disease

Who Is Running the Clinical Trial?

Eric Roselli, M. D.

Lead Sponsor

Trials

1

Recruited

490+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

The 4-branched graft inversion technique used during total arch replacement for acute aortic dissection resulted in shorter circulatory and cardiac arrest times compared to the conventional method, suggesting improved efficiency in the surgical procedure.

This technique demonstrated effective hemostasis without increasing the risk of postoperative complications, making it a viable option for patients undergoing this complex surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-branched graft inversion technique for the distal anastomosis in acute aortic dissection. Zou, Y., Teng, P., Ma, L.[2022]

The hybrid frozen elephant trunk (FET) technique was performed on 86 patients with chronic type B aortic dissection, showing a high follow-up survival rate of 92.3% and a low reintervention rate of 12.5%.

The FET technique effectively prevents complications such as type Ia endoleak and retrograde type A aortic dissection, making it a safer option compared to traditional thoracic endovascular aortic repair, especially for patients with complex aortic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up outcomes after the frozen elephant trunk technique in chronic type B dissection. Charchyan, E., Breshenkov, D., Belov, Y.[2022]

The B-SAFER technique for total arch replacement in patients with multisegment thoracic aortic disease showed early safety results, with an operative mortality rate of 5.6% and a 30-day survival rate of 95% among 178 patients studied.

This innovative approach demonstrated that serious complications were relatively low, with only 2.9% experiencing disabling stroke and 11.4% suffering respiratory failure, indicating that B-SAFER is a promising option for complex aortic repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. Roselli, EE., Vargo, PR., Bakaeen, F., et al.[2023]

The frozen elephant trunk (FET) technique is a safe and effective treatment for patients with acute complicated or chronic Type B aortic dissection, with only one intra-operative death (2%) and no post-operative deaths reported among 41 patients studied.

While the FET technique resulted in a low incidence of non-disabling strokes (10%), it highlighted the need for ongoing aortic re-interventions, as 39% of patients required additional procedures within an average follow-up of 7.7 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Frozen Elephant Trunk Technique for the Treatment of Type B and Type Non-A Non-B Aortic Dissection. Kreibich, M., Siepe, M., Berger, T., et al.[2022]

The hybrid aortic repair using the frozen elephant trunk (FET) technique in a 61-year-old patient with DeBakey I aortic dissection was performed safely without additional left subclavian artery (LSA) debranching, demonstrating effective intraoperative management and sufficient perfusion of the LSA.

Postoperative outcomes were favorable, with no neurological dysfunction or ischemia, and successful thrombotic occlusion of the false lumen observed after 7 days, indicating the efficacy of the procedure in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of On-Site Digital Subtraction Angiography for Left Subclavian Artery Management During Hybrid Aortic Arch Repair in DeBakey I Dissection. Haldenwang, PL., Elghannam, M., Buchwald, D., et al.[2022]

In a study of 426 patients with acute type A aortic dissection, the frozen elephant trunk (FET) technique showed no significant difference in 30-day mortality or neurological dysfunction compared to other surgical methods.

However, long-term survival rates were significantly better for patients who underwent the FET procedure, indicating its potential benefits for improved outcomes in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and long-term results of total arch replacement with the frozen elephant trunk technique for acute type A aortic dissection. Yoshitake, A., Tochii, M., Tokunaga, C., et al.[2022]

The extended branched stented anastomosis frozen elephant trunk repair technique demonstrated significantly shorter operation times and reduced blood product use compared to conventional total arch replacement in patients with acute aortic dissection type A, indicating improved efficiency in surgical management.

Both surgical techniques had comparable safety profiles, with similar rates of surgical deaths (9% for the new technique vs. 10% for conventional surgery) and low complication rates, suggesting that the new method is a viable alternative for emergency repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total arch replacement with extended branched stented anastomosis frozen elephant trunk repair for type A dissection improves operative outcome. Hashizume, K., Matsuoka, T., Mori, M., et al.[2023]

The Total Exclusion of the Non-Stent part of Frozenix using an Everting anastomosis (TENSE) technique was performed on 44 patients with aortic arch disease, resulting in no spinal cord complications or Frozenix kinking, which are common concerns with traditional methods.

Despite a predicted mortality rate of 10.0%, only 4.5% of patients experienced death during hospitalization, and follow-up imaging showed no endoleaks or aneurysmal dilatation, indicating promising early outcomes for this new surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes of the Frozenix J-graft with exclusion of the non-stent part at a single center. Morisaki, A., Takahashi, Y., Fujii, H., et al.[2022]

The study involved 109 patients with non-acute DeBakey type I aortic dissection, using a new soft distal dissection-specific hybrid stent graft, which showed no significant early outcome differences compared to traditional stent grafts.

The soft distal stent graft demonstrated a 100% freedom from distal complications, suggesting it may be more effective in preventing new entry points in the aorta compared to stiffer grafts, although long-term outcomes are still needed for a comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new dissection-specific hybrid stent graft for patients with DeBakey type I aortic dissection. Charchyan, E., Breshenkov, D., Belov, Y.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37802330/

Branched stented anastomosis frozen elephant trunk repair The B-SAFER technique for total arch replacement in a complex cohort of patients with various indications for surgery is a safe and reproducible operation, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04747626

B-SAFER: Branched Stented Anastomosis Frozen ... The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk ...

3. aats.org aats.org/resources/branched-stented-anastomosis-frozen-elephant-trunk-repair-technique-for-total-arch-replacement-early-results-from-a-physician-sponsored-investigational-device-exemption-study

294. Branched Stented Anastomosis Frozen Elephant ... The B-SAFER modified frozen elephant trunk repair technique demonstrate broad applicability by multiple surgeons and excellent safety for total aortic arch ...

4. trialx.com trialx.com/clinical-trials/listings/250896/b-safer-branched-stented-anastomosis-frozen-elephant-trunk-repair/

Branched Stented Anastomosis Frozen Elephant Trunk ... A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38441518/

Branched stented anastomosis frozen elephant trunk repair ... Discussion to: Branched stented anastomosis frozen elephant trunk repair (B-SAFER): Early results from a physician-sponsored investigational device exemption ...

6. jtcvs.org jtcvs.org/article/S0022-5223(23)00895-4/fulltext

Branched stented anastomosis frozen elephant trunk repair B-SAFER is a safe technique for aortic arch replacement, as demonstrated in 178 patients treated for acute and chronic dissection, degenerative ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022522323008954

Branched stented anastomosis frozen elephant trunk repair B-SAFER total arch replacement is a safe and reproducible operation, as demonstrated by early results of a broadly inclusive PS-IDE study.