AMDS Device for Aortic Dissection
(PERSEVERE Trial)
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?
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 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo open surgical repair with AMDS implantation for acute DeBakey type I dissection
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on DANE tears and major adverse events
Treatment Details
Interventions
- AMDS
AMDS is already approved in European Union, United States, Canada for the following indications:
- Acute DeBakey Type I aortic dissection
- Acute DeBakey Type I aortic dissection with evidence of malperfusion
- Acute DeBakey Type I aortic dissection
Find a Clinic Near You
Who Is Running the Clinical Trial?
CryoLife, Inc.
Lead Sponsor
Artivion Inc.
Lead Sponsor
Syneos Health
Collaborator