Aortic Dissection Clinical Trial
— PROTECTOfficial title:
Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2029 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsches Herzzentrum der Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
JOTEC GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive arch remodeling | Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2. | 3-6 months | |
Secondary | All-cause mortality | Rate of all-cause mortality | In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years | |
Secondary | Device-related in-hospital mortality | Rate of device-related in-hospital mortality | Discharge (definition: between 1-29 days) | |
Secondary | Device-related mortality | Rate of device-related mortality | 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years | |
Secondary | Resolution of malperfusion in patients who presented initially with malperfusion | Rate of patients with resolution of malperfusion in patients who presented initially with malperfusion | Discharge (definition: between 1-29 days), 30 days, and 3-6 months | |
Secondary | New disabling (Modified Rankin Scale mRS = 2), permanent (>30 days) stroke | Rate of patients with new disabling (mRS = 2), permanent (>30 days) stroke | Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years | |
Secondary | New disabling (Modified Rankin Scale mRS = 2), transient (< 30 days) stroke | Rate of patients with new disabling (mRS = 2), transient (< 30 days) stroke | Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years | |
Secondary | New paralysis | Rate of patients with new paralysis | Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years | |
Secondary | New paraplegia | Rate of patients with new paraplegia and 5 years | Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years | |
Secondary | 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) | 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years | |
Secondary | Patent innominate artery | Rate of patients with patent innominate artery (< 50% stenosis of the origin of the branch vessels) | Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Source of innominate artery stenosis | Source of innominate artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Patent left carotid artery | Rate of patients with patent left carotid artery (< 50% stenosis of the origin of the branch vessels) | Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Source of left carotid artery stenosis | Source of left carotid artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel) | Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Patent left subclavian artery | Rate of patients with patent left subclavian artery (< 50% stenosis of the origin of the branch vessels) | Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Source of left subclavian artery stenosis | Source of left subclavian artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Absence of distal anastomotic new entry tear (DANE) | Rate of patients with absence of distal anastomotic new entry tear (DANE) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab) | |
Secondary | 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) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab) | |
Secondary | 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) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab) | |
Secondary | 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) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | 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) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Increasing false lumen | Rate of patients with increasing false lumen (= 5mm) in the stented region (Zones 1-3) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Stable false lumen in the stented region | Rate of patients with stable false lumen in the stented region (Zones 1-3) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Decreasing false lumen | Rate of patients with decreasing false lumen (= - 5 mm) in the stented region (Zones 1-3) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Rate of patients with stable or decreasing false lumen | Stable or decreasing false lumen in the stented region (Zones 1-3) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) | |
Secondary | Freedom from AMDS stent removal | Rate of patients with freedom from AMDS stent removal | Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years | |
Secondary | Freedom from AMDS-related reintervention | Rate of patients with freedom from AMDS-related reintervention | Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years | |
Secondary | Freedom from aortic arch reintervention | Rate of patients with freedom from aortic arch reintervention | Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years | |
Secondary | Successful AMDS deployment (at discharge | Rate of patients with successful AMDS deployment (at discharge | Discharge (definition: between 1-29 days) | |
Secondary | 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) | Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab) |
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