At a glance
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Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection: A Pilot Study.
In Brief
A clinical study evaluating Intravascular ultrasound 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA) for Aortic Dissection and Perfusion; Complications. Completed, enrolled 50 participants across 1 site.
Detailed Summary
Aortic dissection is a life-threatening condition caused by a tear in the internal layer of major artery wall (aorta) that carries blood to all body organs, resulting in separation of the aortic wall layers (dissection). The dissected aorta compromises blood flow to any organ, and eventually leads to organ damage (Malperfusion Syndrome). Our goal in this project is to use Intravascular Ultrasound (IVUS) to have real time assessment and confirm any evidence of malperfusion syndrome in the setting of aortic dissection after repairing the original aortic tear. IVUS is a small ultrasound (sound waves) wand that is attached to the top of a thin tube. This tube is inserted into the aorta from the groin. This device takes pictures of the aorta and its major branches, to identify problems with blood flow. Having this real-time and dynamic assessment will help to identify any malperfused organs before leaving the operating room and allow us to address the malperfusion syndrome as quickly as possible to limit complications. Without this technique, identifying the problem can take several days after surgery at which point there can be irreversible complications.
Study Details
Timeline
Interventions
The investigational 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA) is an over the wire catheter-based ultrasound with an 8.2-French profile at the transducer end and 7.0-French shaft diameter. This is run through a 9-French place under surface ultrasound guidance in the common femoral artery. The working length of this catheter is 90 cm, with the ability to imaging a diameter up to 60 mm.7