115 Participants Needed

AMDS Device for Aortic Dissection

(PERSEVERE Trial)

Recruiting at 26 trial locations
EA
PS
Overseen ByPERSEVERE Study Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CryoLife, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.

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 data supports the idea that AMDS Device for Aortic Dissection is an effective treatment?

The available research shows that the AMDS Device for Aortic Dissection is effective in treating acute type A aortic dissection. In a study of 57 cases, the AMDS was used as an alternative to a more extensive surgery, and it showed positive outcomes. Another study highlighted that the AMDS helps stabilize the aorta and improve blood flow, which is crucial for recovery. Additionally, the AMDS has been successfully used in combination with other procedures, like the thoracic endovascular aortic repair, to address complex cases. These studies suggest that the AMDS is a promising treatment option for aortic dissection.12345

What data supports the effectiveness of the AMDS treatment for aortic dissection?

Research shows that the AMDS treatment helps stabilize the aorta (the main artery in the body) and improve blood flow in patients with acute aortic dissection type A, which is a serious condition where the inner layer of the aorta tears. Studies have reported successful outcomes in patients, including better aortic remodeling (restructuring) and closure of the false lumen (an abnormal blood channel).12345

What safety data is available for the AMDS device used in aortic dissection treatment?

The safety data for the AMDS device, also known as the Ascyrus Medical Dissection Stent or AMDS Hybrid Prosthesis, includes several studies and reports. One study evaluated postoperative outcomes in 57 cases of acute type A aortic dissection treated with AMDS, indicating its use as an alternative to total arch replacement. Another study discussed early results of the AMDS Hybrid Prosthesis, highlighting its ability to stabilize the true lumen and improve aortic remodeling. Canadian results from the Dissected Aorta Repair Through Stent Implantation trial also provide insights into its safety and efficacy. Additionally, a case report demonstrated successful use of AMDS in conjunction with thoracic endovascular aortic repair (TEVAR) for residual type B dissection. Lastly, the AMDS has been used in single-stage management of dynamic malperfusion, showing its role as an adjunct in surgical aortic dissection repair.12345

Is the AMDS device generally safe for humans?

The Ascyrus Medical Dissection Stent (AMDS) has been used in several studies for treating aortic dissection, showing it can be safely implanted to stabilize the aorta and improve blood flow. These studies report successful outcomes in patients, suggesting the device is generally safe for human use.12345

Is the AMDS treatment a promising option for aortic dissection?

Yes, the AMDS treatment is promising for aortic dissection. It helps stabilize the aorta, improves blood flow, and can be used in combination with other procedures. It has shown positive results in several cases, making it a valuable option for patients with this condition.12356

How is the AMDS treatment different from other treatments for aortic dissection?

The AMDS treatment is unique because it is a non-covered hybrid prosthesis that can be easily implanted to stabilize the true lumen (the main channel of the blood vessel), improve vessel remodeling, and preserve organ blood flow. Unlike traditional total arch replacement, AMDS offers a less invasive option and can be used in combination with other procedures, such as thoracic endovascular aortic repair (TEVAR), to address complex aortic dissections.12356

Research Team

Wilson Y. Szeto, MD profile ...

Wilson Szeto, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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 am between 18 and 80 years old.
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.
See 29 more

Timeline

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)

Treatment Details

Interventions

  • AMDS
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Acute DeBakey Type I DissectionExperimental Treatment1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Treatment of acute type A aortic dissection with the Ascyrus Medical Dissection Stent in a consecutive series of 57 cases. [2023]
Early Results of a Novel Hybrid Prosthesis for Treatment of Acute Aortic Dissection Type A With Distal Anastomosis Line Beyond Aortic Arch Zone Zero. [2022]
Thoracic Endovascular Aortic Repair Stent Deployed in the Ascyrus Medical Dissection Stent. [2022]
Dissected Aorta Repair Through Stent Implantation trial: Canadian results. [2022]
Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. [2022]
Combining aortic arch dissection stent implantation and root surgery for aortic dissection type A. [2023]