Aortic Dissection > AMDS

AMDS Device for Aortic Dissection (PERSEVERE Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Overseen By Wilson Szeto, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CryoLife, Inc.

No Placebo Group

Approved in 3 jurisdictions

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.

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.

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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.

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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.

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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.

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.

I have poor blood flow in my heart's arteries.

I do not have a medical condition that limits my life expectancy to less than 2 years.

I have a bleeding disorder like hemophilia.

My aortic arch aneurysm is larger than 50 mm.

I have been diagnosed with Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome through genetic testing.

I cannot get CT angiograms for follow-up.

I have signs of severe bowel damage or bleeding in my stomach or intestines.

My tear starts in the arch or beyond the left subclavian artery.

I needed CPR at the time of screening due to a severe heart condition.

I refuse to receive blood transfusions under any circumstances.

I have not had any surgery or interventional procedures within the last 30 days.

I have a body-wide infection.

My chest artery is enlarged, measuring more than 45 mm.

My kidney function is very low (Stage 5).

Participant Groups

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.

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

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Mount Sinai Hospital New York, NY

University of Pennsylvania Philadelphia, PA

University of Florida Gainesville, FL

University of Pittsburgh Medical Center Pittsburgh, PA

More Trial Locations

Who is running the clinical trial?

CryoLife, Inc. Lead Sponsor

Artivion Inc. Lead Sponsor

Syneos Health Collaborator

References

1. Germany 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. [2023] The Ascyrus Medical Dissection Stent (AMDS) has been recently introduced as an alternative for total arch replacement in acute aortic dissection type A (AADA). The aim of this study was to evaluate the postoperative outcomes after AMDS treatment in a large contemporary cohort of AADA patients.

2. Switzerland 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. [2022] Acute aortic dissection type A (AADA) is associated with high perioperative morbidity and mortality. A novel non-covered hybrid prosthesis (Ascyrus Medical Dissection Stent (AMDS) Hybrid Prosthesis, Cryolife/Jotec, Hechingen, Germany) can be easily implanted to stabilize the true lumen (TL), improve remodeling, and preserve organ perfusion. Although developed for implantation in aortic zone 0, occasionally, partial replacement of the aortic arch and further distal implantation of AMDS may appear favorable. Implantation of AMDS with anastomosis line beyond zone 0 has not been described yet.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Thoracic Endovascular Aortic Repair Stent Deployed in the Ascyrus Medical Dissection Stent. [2022] The Ascyrus Medical Dissection Stent (AMDS) has proved to promote false lumen closure at the distal anastomosis in type A dissection repairs. During the past 20 years, open techniques have developed into endovascular repairs. We report a case of thoracic endovascular aortic repair (TEVAR) landed inside an AMDS. A 63-year-old man with hypertension presented with type A aortic dissection. After initial repair with AMDS, he returned for TEVAR to fix residual type B dissection. A proper seal was created between the AMDS and TEVAR stents, demonstrating a successful off-label use of the AMDS stent.

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

Dissected Aorta Repair Through Stent Implantation trial: Canadian results. [2022] We describe the Canadian results of the Ascyrus Medical Dissection Stent (AMDS), a novel partially uncovered aortic arch hybrid graft implanted antegrade during hypothermic circulatory arrest to promote true lumen expansion and enhance aortic remodeling.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. [2022] Organ malperfusion remains challenging, causing complications associated with acute DeBakey I dissections. We describe the results of malperfusion management after implantation of the Ascyrus Medical Dissection Stent (AMDS; Ascyrus Medical, Boca Raton, FL), an adjunct to current surgical aortic dissection repair.

6. England pubmed.ncbi.nlm.nih.gov

Combining aortic arch dissection stent implantation and root surgery for aortic dissection type A. [2023] Acute aortic dissection type A (AADA) is associated with high perioperative morbidity and mortality. A novel non-covered hybrid prosthesis (AMDS, CryoLife, Kennesaw, USA) can be easily implanted to stabilize the true lumen. However, the role of AMDS for patients requiring additional aortic root surgery has not been described.