Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection (NCT03894033) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection
Germany301 participantsStarted 2019-03-12
Plain-language summary
The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas".
In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels.
AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* ≥18 and ≤ 80 years of age (male or female)
* One of the following diagnosed within 14 days:
* Acute DeBakey type I dissection based on CT angiography; or
* IMH based on CT angiography
Exclusion Criteria
General Exclusion Criteria:
* \< 18 years of age or \> 80 years of age (male or female)
* Unwilling to comply with the follow-up schedule
* Refusal to give Informed Consent
Medical Exclusion Criteria:
* Uncontrolled systemic infection
* Uncontrollable anaphylaxis to iodinated contrast
* Known allergy(ies) to nitinol and/ or PTFE
* Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
* Preoperative coma
Anatomical Exclusion Criteria:
* Any pathology of mycotic origin
* Subacute or chronic dissection of the ascending aorta and aortic arch (\>14 days after the index event)
* Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
* Extensive thrombus or calcification in the aortic arch as defined by CT angiography
* Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.