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Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection
Sponsor: JOTEC GmbH
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.
Official title: Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
301
Start Date
2019-03-12
Completion Date
2030-06-30
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Ascyrus Medical Dissection Stent (AMDS)
The device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
Locations (1)
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany