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)

490 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.

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 data supports the effectiveness of the B-SAFER treatment for aortic dissection?

The B-SAFER treatment, which is a type of frozen elephant trunk (FET) technique, has shown promising early results in treating complex aortic diseases, as it combines elements of stented anastomosis and hybrid stent grafts. Studies on similar FET techniques have demonstrated positive outcomes in both acute and chronic aortic dissections, suggesting potential effectiveness for B-SAFER in aortic dissection cases. ^{1 2 3 4 5}

Is the B-SAFER technique generally safe for humans?

The B-SAFER technique, also known as the frozen elephant trunk repair, has been studied for various aortic conditions and is considered favorable and safe, although some adverse events have been noted with certain grafts. Safety has been associated with the complexity of the procedure and the specific techniques used to manage different parts of the aorta. ^{2 4 5 6 7}

What makes the B-SAFER treatment unique for aortic dissection?

The B-SAFER treatment is unique because it combines a branched stented anastomosis with a frozen elephant trunk repair, which allows for total arch replacement without unnecessary exposure of cervical arteries, potentially reducing surgical risk compared to conventional methods. ^{1 5 7 8 9}

Research Team

Eric Roselli, M. D.

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A new dissection-specific hybrid stent graft for patients with DeBakey type I aortic dissection. [2022]

2. Germany 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Four-branched graft inversion technique for the distal anastomosis in acute aortic dissection. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The Frozen Elephant Trunk Technique for the Treatment of Type B and Type Non-A Non-B Aortic Dissection. [2022]

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

Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. [2023]

6. China pubmed.ncbi.nlm.nih.gov

Early outcomes of the Frozenix J-graft with exclusion of the non-stent part at a single center. [2022]

7. United States 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. [2022]

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

Total arch replacement with extended branched stented anastomosis frozen elephant trunk repair for type A dissection improves operative outcome. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Follow-up outcomes after the frozen elephant trunk technique in chronic type B dissection. [2022]