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

NCT03894033 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 301

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

  • Aortic Dissection
  • Acute DeBakey I Dissection
  • Acute Type A Dissection
  • Intramural Hematoma

Interventions

DEVICE

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.

Sponsors & Collaborators

  • JOTEC GmbH

    lead INDUSTRY

Principal Investigators

  • Jörg Kempfert, Prof. · Deutsches Herzzentrum der Charité

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2026-06-30
Completion
2030-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894033 on ClinicalTrials.gov