CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
Aspirin +2 moredrug
Likely dose
Aspirin 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01758614
NCT01758614Phase 3Completed

The Carotid and Middle Cerebral Artery Occlusion Surgery Study

Xuanwu Hospital, Beijing·interventional·Posted Jan 1, 2013·Updated Nov 12, 2021

In Brief

A Phase 3 clinical trial evaluating bypass surgery, Aspirin, and 1 other intervention for Carotid Artery Occlusion and 2 related conditions. Completed, enrolled 330 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2013
Enrollment StartJun 6, 2013
Primary CompletionMar 2, 2018
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.5 years ago

Interventions

bypass surgeryprocedure

all participants in this group will be performed EC-IC bypass surgery

Aspirindrug

all participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day

Clopidogreldrug