Introduction/Purpose Tortuosity can infrequently impact femoral or radial vascular access for thrombectomy or thrombaspiration. Direct carotid access (DCA) is a well‐known technique safely used for diagnostic angiography studies for > 60 years. However, the limitation for endovascular procedures using a DCA is that it requires manual artery compression or surgery to close the access site. Off‐label use of currently approved percutaneous closure devices has resulted in more than 20% of dissections, neck hematoma, stroke, and death. More recently, transcarotid artery revascularization (TCAR), which involves an incision in the neck, has been used for direct carotid access for acute stroke patients. Material and Methods We have developed a percutaneous 8 Fr OD, 9 Fr ID, kink‐resistance soft‐tip super flexible thin‐line access sheath using a 0.018” microwire with a unique flush‐through atraumatic dilator for angiography without the need to remove micro‐guide wire and suture DCA closure system based on a single suture with an Auto‐Knot feature. The one‐step integrated access sheath and closure device eliminates external exchanges. The thin‐line access sheath has a distal radiopaque and echogenic marker and a side port for an over‐the‐wire (OTW) deployment of suture, allowing constant preservation of the access to the carotid artery during closure. Results Preclinical benchtop and animal studies using ultrasound for DCA and the access sheath and closure system showed successful reliability of the single suture and Auto‐Knot system and sealing of the 8Fr access. The animals were subjected to arterial hypertension and placed on anticoagulation to simulate clinically challenging conditions. No dissections of the common carotid arteries were seen. A preliminary clinical safety study is ongoing and will be presented. Our experience shows a short learning curve for physicians of less than 5 minutes with shortened procedural time to access the brain for acute revascularization for stroke patients with minimal blood loss during the closure due to the ease of use of the closure device. Conclusions A simplified direct carotid large bore access and closure system may eliminate delay in access for thrombectomy in acute ischemic stroke. It allows for a percutaneous temporary flow arrest and reversal for carotid stenting and enables robotic‐assisted direct access to the carotid artery.
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