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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
Germany
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Contact Information
Primary
Emilie Chilaud
emilie.chilaud@artivion.com
+33 672 415 101
Backup
Svitlana Marchand
svitlana.marchand@artivion.com
+33 685 365 793
Time Frame
Start Date: 2019-03-12
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Leads: JOTEC GmbH

This content was sourced from clinicaltrials.gov