"Evaluation of the impact of the dose of heparin on the occurrence of DWI ischemic lesions after embolization of unruptured intracranial aneurysm" "HARMONI"

Condition studied

Intracranial aneurysms

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percentage of the presence of at least one recent ischemic lesion visible on diffusion-weighted MRI at 24 hours postoperatively, in each treatment arm.

Endpoint detail

Rate of intraoperative angiographic thromboembolic events in each arm, Proportion of subjects with more than 5 punctate ischemic lésions, or a territorial ischemic stroke visible on diffusion-weighted MRI at 24 hours postoperatively, in each arm., Mean volume of recent ischemic lesions on diffusion-weighted MRI at 24 hours postoperatively, in each arm, Rate of subjects with symptomatic ischemic stroke within 24 hours postoperatively , in each arm., NIHSS score at 24 hours postoperatively in each arm, Rate of major hemorrhagic events (intraoperative or within the first 24 hours postoperatively) in each arm, Rate of minor hemorrhagic events (intraoperative or within the first 24 hours postoperatively), Proportion of subjects who experienced any ischemic event within 24 hours after the procedure.