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.
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.