PICASSO (Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem Lesion or Local Occlusion) Thrombectomy Randomized Trial: Study Protocol and Rationale.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Al Kasab Sami, Nguyen Thanh N, Abdalkader Mohamad, Rai Ansaar, Boo Sohyun, Kass-Hout Tareq, Hurley Michael, Sultan-Qurraie Ali, Lin Eugene, Given Curtis, Elijovich Lucas, Badruddin Aamir, Janjua Nazli, Jung Richard, Khandelwal Priyank, Southwood Christopher, Majjhoo Aniel, Guerrero Waldo R, Mueller-Kronast Nils, Alshekhlee Amer, Martinez-Gutierrez Juan Carlos, Ezzeldin Mohamad, Cress Marshall, Niazi Muhammad, Paul Alexandra, Snelling Brian, Razak Anmar, Grandhi Ramesh, Morgan Larry, Settecase Fabio, English Joey, Fernandez Patricia, Zacharatos Haralabos, Alexander Matthew, Asif Kaiz, Kicielinski Kimberly P, Cuellar Hugo, Limaye Kaustubh, Abraham Michael, Yaghi Shadi, de Havenon Adam, Almekhlafi Mohammed, Linfante Italo, Teleb Mohamed Sameh, Thomalla Gotz, Gress Daryl R, Smith Wade S, Brown Scott, Olvany Jasmine, Ibrahim Laila, Khan Niha, Zaidat Osama O
Аннотация
METHODS: PICASSO is a prospective, randomized, controlled, multicenter, open label, assessor-blinded acute ischemic stroke trial with pragmatic design enrolling up to 404 patients at up to 60 sites. Patients with anterior circulation large vessel occlusion with severe stenosis or complete occlusion (70%-100%) of the extracranial carotid artery who meet the imaging and clinical eligibility criteria will be randomized in a 1:1 ratio to undergo mechanical thrombectomy of the intracranial lesion plus emergent stenting of the extracranial lesion versus mechanical thrombectomy plus no stenting up to 16 hours from last known well.
RESULTS: The primary efficacy outcome is the ordinal shift of 90-day modified Rankin Scale (mRS) score. The primary analysis will be based on the intention-to-treat principle stratified by the Alberta Stroke Program Early CT [Computed Tomography] Score (7-8 versus 9-10), degree of proximal carotid stenosis (70%-90% versus 91%-100%), NIHSS (≤ 10 versus > 10), and use of intravenous thrombolysis. The primary safety outcome is symptomatic intracranial hemorrhage. Secondary outcomes include 1-year mRS (dichotomized and ordinal), successful reperfusion, and vessel patency at follow-up. Subgroup analyses will include comparison of intravenous versus oral antiplatelets in the stenting arm, and treatment of proximal intracranial occlusion first versus a simultaneous approach.
CONCLUSION: PICASSO is a pragmatic randomized trial, designed to address the safety and efficacy of mechanical thrombectomy with acute carotid stenting versus nonacute stenting with or without delayed revascularization treatment in patients with anterior circulation large vessel occlusion and concomitant extracranial severe stenosis or complete occlusion.
CLINICAL TRIAL REGISTRATION: NCT05611242.