Department of neurosurgery, Xuanwu hospital
Beijing, Beijing Municipality, 100053, China
NCT Number: NCT01758614
The recently published Carotid Occlusion Surgery Study (COSS) failed to show a benefit of extracranial-intracranial (EC-IC) bypass surgery over medical therapy in patients with symptomatic hemodynamically significant carotid occlusion. Since then on, different controversies have been raised on several aspects including the study population, qualifications of surgeons and hemodynamic evaluation.
In COSS protocol, the primary inclusion population is the patient demonstrating occlusion of unilateral ICA while the contralateral ICA less than 50% stenosis. Because of the enrollment problems, in the final result report, 18% patients suffered from contralateral ICA stenosis more than 50%. As we known, COSS utilized oxygen extraction fraction (OEF) ratio by PET as the criterion of hemodynamic evaluation. Bilateral ICAs lesion will disturbed the ratio even the identifying the subgroup of patients with hemodynamic insufficiency.
As an interventional trial, the COSS should ensure the certification for the experienced surgeons. While for expanding the number of centers and enhancing recruitment, COSS made some concessions on the surgeons training and certification. The 15% postoperative event rate is not the best that can be achieved according to recent surgical technical development.
The cerebral hemodynamic insufficiency has been considered as the primary pathophysiological factor for patients with ICA or MCA occlusion. For these patients, antiplatelet therapy is not likely to prevent hemodynamic stroke.EC-IC bypass surgery probably will be the possible effective therapy.
These underlying assumptions deserved further exploration and more strict research.So the CMOSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with medical therapy in patients with symptomatic hemodynamically significant carotid occlusion.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100053, China
Patients with symptoms of cerebral or retinal ischemia associated with ipsilateral internal carotid artery (ICA) occlusion have an annual risk of 5-8% of recurrent ischemic stroke. While in China, the incidence of middle cerebral artery (MCA) occlusion is higher than in western countries. The annual risk of recurrent ischemic stroke in patients with symptomatic ICA or MCA occlusion has not improved over the years. The proportion of recurrence that was minor disabling was rather high.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
all participants in this group will be performed EC-IC bypass surgery
Other names: EC-IC bypass surgery
all participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day
Other names: Aspirin 100mg per day or clopidogrel 75mg per day
Time frame: up to 30 days
The number of participants who suffer from all stroke or death within 30 days after EC-IC bypass surgery or medical therapy
Time frame: up to 24 months
the number of participants who suffer from ipsilateral ischemic stroke within 24 months of randomization
Time frame: up to 24 months of randomization
the number of participants who suffer from severe TIA within 24 months of randomization
Time frame: during 30 days to 24 months
the number of participants who suffer from all stroke or death during 30 days to 24 months
Time frame: at 7 days, 30 days, 6 months, 12 months and 24 months
the changes from baseline in mRS, NIHSS and Barthel Index at 7 days, 30 days, 6 months, 12 months and 24 months
Time frame: at 24 months
the changes from baseline of CBF ratio in CT perfusion at 24 months
Time frame: up to 30 days
the number of participants who suffer from all kinds of adverse events related to surgery within 30 days in the EC-IC bypass surgery group
Xuanwu Hospital, Beijing
Other
Acronym: CMOSS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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