Dissected Aorta Repair Through Stent Implantation (DARTS): A POST-MARKET REGISTRY

Study Overview
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Brief Summary
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This study is for participants who have been diagnosed with an acute aortic dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/ intramural hematoma) treated with the AMDS device. 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). The blood is now flowing through both channels. The purpose of this study is to investigate the performance and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) following regulatory approval.

Detailed Description
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Patients diagnosed with an acute aortic dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/ intramural hematoma) treated with the AMDS device are being asked to take part in the DARTS Post-Market Registry to collect further data about acute DeBakey I dissections/ IMH and to further explore the benefits of the AMDS as a treatment modality. In a healthy aorta (the vessel that supplies blood to most of your body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). In this case a tear has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen). The blood is now flowing through both channels. Although the first segment of the aorta can be replaced, this conventional operation only treats the segment immediately above the heart. Because of the complexity of the patients medical condition and technical limitations, the remainder of the separated channel in the hard to reach area is normally left untreated. Following this initial lifesaving surgery, the part of the separated channel that is not treatable by standard surgery may expand, weakening the wall of the aorta further which can cause rupture and death. To prevent this, 40-50% of patients require additional invasive surgeries. It is normal procedure for the cardiac surgeons to repair your tear by putting a graft in the first portion of the aorta immediately above the heart. The AMDS device in the DARTS Trial (NCT03035643) has shown significant benefits for the patients in terms of positive remodeling and healing of the aortic arch in addition to effective management of malperfusion. This registry sets out to gather additional information about acute aortic dissections and to further explore the clinical benefits of the AMDS treatment. The AMDS is a stent made of Teflon fabric sewn to a tubular Nitinol (nickel and titanium) stent. The stent is not covered with any cloth material and when placed in the aorta allows blood flow to the sides of the aorta. The stent is placed inside the aorta and allowed to expand to open up the aorta. It will help to close the anastomotic entry tear created during the standard of care operation, reduce the flow and pressure in the false lumen, and supoort, expand and pressurize the true lumen.

Official Title
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Dissected Aorta Repair Through Stent Implantation (DARTS): A POST-MARKET REGISTRY

Conditions
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Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection

Intervention / Treatment
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* Device: Ascyrus Medical Dissection Stent (AMDS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age or ≤80 years of age (male or female) One of the following diagnosed within 0-14 days: A. Acute DeBakey type I dissection based on CT angiography; or B. Acute DeBakey type I IMH based on CT angiograph 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 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 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) 12. Extensive thrombus or calcifications in the aortic arch as defined by CT angiography 13. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | The number of patients with mortality related to the treatment device. | 4 weeks | 
| Disabling permanent stroke. The number of patients with neurological deficit related to the treatment device. | The number of patients with neurological deficit related to the treatment device. | 4 weeks | 
| Paralysis and paraplegia. The number of patients with paralysis or paraplegia related to the treatment device. | The number of patients with paralysis or paraplegia related to the treatment device. | 4 weeks | 
| Aortic injury associated with the implantation of the device. The number of patients with aortic injury related to the treatment device. | The number of patients with aortic injury related to the treatment device. | 4 weeks | 
| Aortic arch vessel branch patency compromise. The number of patients with >75% stenosis of the Innominate and left common carotid arteries following device deployment. | The number of patients with >75% stenosis of the Innominate and left common carotid arteries following device deployment. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of proximal anastomotic entry tear. The number of patients with closure of the entry to the false lumen at the anastomosis with the treatment device. | The number of patients with closure of the entry to the false lumen at the anastomosis with the treatment device. | 12 months | 
| True lumen expansion. The number of patients with expansion of the true lumen with the treatment device. | The number of patients with expansion of the true lumen with the treatment device. | 12 months | 
| Resolution of dynamic malperfusion. The number of patients with resolution of dynamic malperfusion with the treatment device. | The number of patients with resolution of dynamic malperfusion with the treatment device. | 4 weeks | 
| Need for stent removal. | Stent placement and retention. The number of patients requiring removal of the stent. | 12 months | 
| Successful device deployment. | The number of patients with technically successful stent placement and retention. | Immediate. | 
| Radiographic evidence of aortic remodeling. The number of patients exhibiting radiographic evidence of positive remodeling. | The number of patients exhibiting radiographic evidence of positive remodeling. | 6 months and 12 months. |