Aortic Dissection Clinical Trial
Official title:
Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.
DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and
there is equipoise in available literature with regards to the best operative strategy and
patient selection criteria. Hemiarch repair is current standard of care in most centers but
extended arch repair is gaining popularity aiming to address early post-operative
malperfusion and improve long term aortic remodeling.
HEADSTART is a randomized controlled prospective trial of patients presenting to
participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled
and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'.
Pre-operative, early post-operative and long term follow clinical and CT imaging data will be
collated on a centralized database and at a core lab respectively.
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