An observational study in Aortic Dissection, Acute DeBakey I Dissection and Acute Type A Dissection, sponsored by JOTEC GmbH. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by JOTEC GmbH · Observational
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.
Observational, prospective and retrospective, non-randomized, non-interventional study to investigate the performance and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural hematomas (IMH).
Participating physicians will be asked to provide their observations collected during routine care for patients they had decided to treat with AMDS. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
A total number of 300 subjects will be enrolled in up to 30 sites in Europe and Canada. The AMDS will be implanted according to the instructions for use and at the discretion of the treating physician.
This registry was initiated by Ascyrus Medical GmbH in August 2019 (DARTS PM Registry). About 70 patients were enrolled at that time by German and Canadian sites under previous protocol. The patient's enrollment was put on-hold and the study has been re-started as PROTECT Registry with updated study documents as per JOTEC's standard operating procedures upon Ethics Committees approvals.
Patients already included in DARTS PM Registry will be re-consented (where applicable as per local regulatory requirements) to allow the retrospective and prospective collection of additional data points not included in the initial version of the protocol. It is also planned to retrospectively include up to 150 subjects of the 300 targeted subjects, which have been treated with AMDS and who consent to the collection of their data (if required by national law) and are willing to continue in this registry, if applicable.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's enrollment of 301 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One of the following diagnosed within 14 days:
Exclusion Criteria
General Exclusion Criteria:
Medical Exclusion Criteria:
Anatomical Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: AMDS Arch Remodeling Therapy
Positive arch remodeling
Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.
Time frame: 3-6 months
All-cause mortality
Rate of all-cause mortality
Time frame: In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Device-related in-hospital mortality
Rate of device-related in-hospital mortality
Time frame: Discharge (definition: between 1-29 days)
Device-related mortality
Rate of device-related mortality
Time frame: 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Resolution of malperfusion in patients who presented initially with malperfusion
Rate of patients with resolution of malperfusion in patients who presented initially with malperfusion
Time frame: Discharge (definition: between 1-29 days), 30 days, and 3-6 months
New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) stroke
Rate of patients with new disabling (mRS ≥ 2), permanent (\>30 days) stroke
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke
Rate of patients with new disabling (mRS ≥ 2), transient (\< 30 days) stroke
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paralysis
Rate of patients with new paralysis
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
New paraplegia
Rate of patients with new paraplegia and 5 years
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
New aortic rupture associated with the implantation of the device
Rate of patients with new aortic rupture associated with the implantation of the device (procedure or AMDS related)
Time frame: 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
Patent innominate artery
Rate of patients with patent innominate artery (\< 50% stenosis of the origin of the branch vessels)
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of innominate artery stenosis
Source of innominate artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left carotid artery
Rate of patients with patent left carotid artery (\< 50% stenosis of the origin of the branch vessels)
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left carotid artery stenosis
Source of left carotid artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Patent left subclavian artery
Rate of patients with patent left subclavian artery (\< 50% stenosis of the origin of the branch vessels)
Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
Source of left subclavian artery stenosis
Source of left subclavian artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Absence of distal anastomotic new entry tear (DANE)
Rate of patients with absence of distal anastomotic new entry tear (DANE)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Increasing true lumen
Rate of patients with increasing true lumen \[change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable true lumen
Rate of patients with stable true lumen \[change in diameter at the maximal diameter location within each Zone which is between a 5 mm reduction and a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
Stable or increasing true lumen in the stented region
Rate of patients with stable or increasing true lumen in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing true lumen
Rate of patients with decreasing true lumen \[change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm reduction in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Increasing false lumen
Rate of patients with increasing false lumen (≥ 5mm) in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Stable false lumen in the stented region
Rate of patients with stable false lumen in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Decreasing false lumen
Rate of patients with decreasing false lumen (≤ - 5 mm) in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Rate of patients with stable or decreasing false lumen
Stable or decreasing false lumen in the stented region (Zones 1-3)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Freedom from AMDS stent removal
Rate of patients with freedom from AMDS stent removal
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from AMDS-related reintervention
Rate of patients with freedom from AMDS-related reintervention
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Freedom from aortic arch reintervention
Rate of patients with freedom from aortic arch reintervention
Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
Successful AMDS deployment (at discharge
Rate of patients with successful AMDS deployment (at discharge
Time frame: Discharge (definition: between 1-29 days)
Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
Rate of patients with completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Plan to share: No — All study participant data will be de-identified.
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Jun 2026, 87 months after the start.
Of 48 observational studies under Aortic Dissection, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 135. This study's planned 87 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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