Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

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.

NCT Number	NCT03894033
Lead Sponsor	JOTEC GmbH
Conditions	Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection, Intramural Hematoma
Enrollment	301 participants
Start Date	2019-03-12
Primary Completion	2026-06-30 (estimated)
Study Completion	2030-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-09