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New stent registry aims to improve aortic dissection outcomes

NCT ID NCT03894033

Disease control Sponsor: JOTEC GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a registry that collects information on the AMDS stent, a device used to treat a life-threatening tear in the aorta (the main artery). The registry includes 301 adults aged 18-80 with acute DeBakey type I aortic dissection or intramural hematoma. The goal is to see how well the stent helps the aorta heal and to track patient survival and complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

301 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic disorder Aortic Dissection cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute debakey I dissection Acute type A dissection Aortic dissection Intramural hematoma

Contacts and locations

Locations

  • Deutsches Herzzentrum der Charité

    Berlin, State of Berlin, 13353, Germany

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