AMDS Device for Aortic Dissection

(PERSEVERE Trial)

Not currently recruiting at 28 trial locations

Overseen By PERSEVERE Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CryoLife, Inc.

Disqualifiers: Cancer, Heart failure, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a device called the AMDS (Ascyrus Medical Dissection Stent) to determine its safety and effectiveness in treating acute DeBakey type I dissection. This serious condition involves a tear in the main artery (aorta) that can disrupt blood flow to vital organs. The trial seeks participants diagnosed with this condition within the last 14 days who experience issues like poor blood flow to the brain or kidneys. Individuals facing these specific problems may be suitable candidates for the study. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for guidance.

Will I have to stop taking my current medications?

The trial protocol 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 AMDS device is safe for treating aortic dissection?

Research shows that the AMDS device has been tested for safety in patients with acute DeBakey type I aortic dissection, a serious heart condition. In earlier studies, researchers used the AMDS during open-heart surgery. These studies provide insight into how well patients tolerate the device.

The results indicate that while risks exist, the device addresses specific challenges of this condition. Some patients experienced negative side effects, which are common in major heart surgeries. Overall, the device aims to improve outcomes by enhancing blood flow during and after surgery.

Prospective trial participants should discuss with their doctor to understand how these findings might relate to their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AMDS device for treating acute DeBakey Type I aortic dissection stands out because it introduces a novel method of managing this life-threatening condition. Traditional treatments often involve surgical grafts and extensive repair, which can be highly invasive and complex. However, the AMDS device is delivered directly into the aorta through an innovative delivery system that simplifies the process and may reduce surgery time. Researchers are excited about this device because it might offer a more efficient, less invasive alternative to current surgical procedures, potentially improving patient outcomes and recovery times.

What evidence suggests that the AMDS device is effective for aortic dissection?

Research has shown that the AMDS device, which participants in this trial will receive, may help treat acute DeBakey type I aortic dissection. In one study, 83% of patients experienced better blood flow to their organs, and 74% had improved blood flow to their kidneys within 30 days. Early results also indicate a significant reduction in major complications and new tears in the aorta, common issues with this condition. This device is specifically designed to address these challenges. Overall, these findings suggest that AMDS could be an effective treatment option for patients with this type of aortic dissection. ^{2 3 4 6 7}

Who Is on the Research Team?

Wilson Szeto, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with acute DeBakey type I aortic dissection diagnosed within the past two weeks, showing malperfusion symptoms. Excluded are those institutionalized by order, with signs of bowel infarction or bleeding, severe infections, CT angiogram ineligibility, bleeding disorders, certain heart and vascular conditions, pregnancy/breastfeeding status, unwillingness to follow the study protocol or accept blood transfusions.

Inclusion Criteria

I have poor blood flow to my brain, organs, or limbs.

I was diagnosed with a type I aortic dissection less than 14 days ago.

Exclusion Criteria

I have an infection caused by fungi.

I have an abnormal connection between my aorta and another organ.

I need surgery on my aorta or its branches as recommended by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open surgical repair with AMDS implantation for acute DeBakey type I dissection

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on DANE tears and major adverse events

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMDS

Trial Overview The PERSEVERE trial is testing AMDS's safety and effectiveness in treating patients with acute DeBakey type I dissection through open surgical repair. It's a prospective (forward-looking), non-randomized study conducted across multiple centers.

How Is the Trial Designed?

Group I: Acute DeBakey Type I Dissection Experimental Treatment 1 Intervention

In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.

AMDS is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as AMDS Hybrid Prosthesis for:

• Acute DeBakey Type I aortic dissection

Approved in United States as AMDS Hybrid Prosthesis for:

• Acute DeBakey Type I aortic dissection with evidence of malperfusion

Approved in Canada as AMDS Hybrid Prosthesis for:

• Acute DeBakey Type I aortic dissection

Who Is Running the Clinical Trial?

CryoLife, Inc.

Lead Sponsor

Trials

18

Recruited

2,200+

Artivion Inc.

Lead Sponsor

Trials

7

Recruited

1,500+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Published Research Related to This Trial

The Ascyrus Medical Dissection Stent (AMDS) was successfully implanted in all 16 patients with acute type A aortic dissections, demonstrating a low 30-day mortality rate of 6.3% and no device-related complications.

Follow-up imaging showed that 91.7% of patients experienced complete or partial thrombosis and remodeling of the aortic arch and proximal descending thoracic aorta, indicating that the AMDS effectively promotes positive aortic remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissected Aorta Repair Through Stent Implantation trial: Canadian results. Bozso, SJ., Nagendran, J., MacArthur, RGG., et al.[2022]

In a study of 57 patients with acute aortic dissection type A treated with the Ascyrus Medical Dissection Stent (AMDS), the in-hospital mortality rate was 16%, which is lower than the predicted 22% mortality risk, indicating the AMDS may be a safe treatment option.

Postoperative complications were observed in some patients, including acute renal insufficiency (37%) and central stent collapse (9%), but the latter did not affect 30-day mortality, suggesting that while complications can occur, the overall outcomes remain favorable with careful patient evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute type A aortic dissection with the Ascyrus Medical Dissection Stent in a consecutive series of 57 cases. Luehr, M., Gaisendrees, C., Yilmaz, AK., et al.[2023]

The Ascyrus Medical Dissection Stent (AMDS) effectively promotes closure of the false lumen in type A aortic dissection repairs, demonstrating its utility in complex aortic surgeries.

In a case study involving a 63-year-old man, the AMDS was successfully used in conjunction with thoracic endovascular aortic repair (TEVAR) to address residual dissection, showcasing its potential for off-label applications in enhancing aortic repair outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic Endovascular Aortic Repair Stent Deployed in the Ascyrus Medical Dissection Stent. O'Brien, DJ., White, A., Bozso, SJ., et al.[2022]

In a study of 28 patients with acute aortic dissection type A who received the Ascyrus Medical Dissection Stent (AMDS) hybrid prosthesis, 87.5% of survivors showed no signs of clinical malperfusion, indicating a high safety profile for this intervention.

Postoperative imaging revealed that all patients had an open true lumen, and the AMDS implantation can be safely performed even when the anastomosis is placed beyond the standard zone 0, combining the benefits of arch remodeling while minimizing risks like spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Results of a Novel Hybrid Prosthesis for Treatment of Acute Aortic Dissection Type A With Distal Anastomosis Line Beyond Aortic Arch Zone Zero. Mehdiani, A., Sugimura, Y., Wollgarten, L., et al.[2022]

In a study of 120 patients undergoing surgery for acute aortic dissection type A, the use of a novel non-covered hybrid prosthesis (AMDS) during aortic root surgery was found to prolong cardiopulmonary bypass and circulatory arrest times, but did not significantly affect short-term outcomes such as morbidity or mortality.

Postoperative complications like dialysis and stroke rates were comparable between patients who received the AMDS and those who did not, suggesting that the AMDS implantation is a safe option when combined with aortic root surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining aortic arch dissection stent implantation and root surgery for aortic dissection type A. Immohr, MB., Mehdiani, A., Bauer, SJ., et al.[2023]

The Ascyrus Medical Dissection Stent (AMDS) was successfully implanted in all 26 patients with acute DeBakey I aortic dissections, demonstrating its effectiveness in managing organ malperfusion during emergency surgical repair.

After 30 days, 95.5% of vessel malperfusions resolved without additional procedures, and all patients who presented with paralysis showed complete resolution, indicating that AMDS is a promising strategy for concurrent malperfusion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Bozso, SJ., Nagendran, J., Chu, MWA., et al.[2022]

Citations

1. investors.artivion.com investors.artivion.com/news-releases/news-release-details/artivion-announces-presentation-late-breaking-data-amds-1

Artivion Announces Presentation of Late-Breaking Data from ... 30-day Data from the AMDS PERSEVERE Trial Demonstrates Visceral Malperfusion Resolution in 83%, and Renal Malperfusion Resolution in 74% of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39116932/

A novel hybrid prosthesis for open repair of acute DeBakey ... Early results show significant reductions in major adverse events and distal anastomotic new entry tears, successfully meeting both primary ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522324006779

A novel hybrid prosthesis for open repair of acute DeBakey ... The PERSEVERE study evaluates the safety and effectiveness of the AMDS Hybrid prosthesis, a novel bare metal stent, in patients presenting with preoperative ...

4. artivion.com artivion.com/product/amds-hybrid-prosthesis/

AMDS™ Hybrid Prosthesis The world's first device designed specifically to address the unique challenges of acute type A aortic dissection, specifically DeBakey Type I (ADTI).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084383/

The Ascyrus Medical Dissection Stent: A One-Fits-All Strategy ... Current study results investigating outcomes after AMDS implantation in DeBakey type I dissection. Author and Year, Number of. Patients ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/H230007B.pdf

SUMMARY OF SAFETY AND PROBABLE BENEFIT (SSPB) The PERSEVERE IDE study evaluated AMDS in the open surgical treatment of patients with acute DeBakey type I aortic dissection, with evidence of ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/H230007C.pdf

H230007 AMDS Indications for Use The AMDS Hybrid Prosthesis is indicated for use in patients with acute DeBakey Type I aortic dissections with malperfusion (including cerebral, ...