The Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS)

November 11, 2021 updated by: Xuanwu Hospital, Beijing

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Department of neurosurgery, Xuanwu hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ranging between 18 and 65 years;
  • Digital subtraction angiography imaging studies demonstrating occlusion of unilateral ICA or MCA;
  • Digital subtraction angiography imaging studies demonstrating less than 50% stenosis of any other vessels especially contralateral ICA and MCA;
  • Modified Rankin Scales (mRS) 0-2;
  • Qualifying TIA or ischemic stroke in the territory of the occluded ICA or MCA must have occurred within the past 12 months;
  • The most recent stoke attacked more than 3 weeks ago;
  • The neurological deficit must be stable for more than 1 month;
  • No massive cerebral infarction (>50% of the MCA territory) in CT or MRI study;
  • CT Perfusion demonstrates "misery perfusion" ;
  • Competent to give informed consent;
  • Legally an adult;
  • Geographically accessible and reliable for follow-up;

Exclusion Criteria:

  • Other neurovascular disease (such as cerebral aneurysm or arteriovenous malformation) conditions likely to cause focal cerebral ischemia;
  • Known unstable angina or myocardial infarction within recent 6 months;
  • Pregnant or perinatal stage women;
  • Blood coagulation dysfunction;
  • Any diseases likely to death within 2 years;
  • Past history of EC-IC bypass surgery;
  • Any contraindications or allergy to aspirin or clopidogrel;
  • Any heart disease likely to cause cerebral ischemia including prosthetic valves, infective endocarditis, atrial fibrillation, sick sinus syndrome, myxoma and cardiomyopathy with ejection fraction less than 25%;
  • Allergy to iodine or radiographic contrast media;
  • Serum creatinine > 3mg/dl;
  • Uncontrolled diabetes mellitus (fasting blood glucose >16.7mmol/l);
  • Uncontrolled hypertension (systolic BP >180 mmHg, diastolic BP>110 mmHg);
  • Severe liver dysfunction [alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 3 times of normal level];
  • Concurrent participation in any other experimental treatment trial;
  • Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bypass group
all the participants in this group will be performed EC-IC bypass surgery
Procedure: bypass surgery
all participants in this group will be performed EC-IC bypass surgery
Other Names:
  • EC-IC bypass surgery
Active Comparator: medical group
all the participants in this group will be given medical therapy including aspirin 100mg per day or clopidogrel 75mg per day
Drug: Clopidogrel
Drug: Aspirin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of participants who suffer from stroke or death after EC-IC bypass surgery or medical therapy
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
up to 30 days
the number of participants who suffer from ipsilateral ischemic stroke
Time Frame: up to 24 months
the number of participants who suffer from ipsilateral ischemic stroke within 24 months of randomization
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of participants who suffer from severe transit ischemic attack (TIA)
Time Frame: up to 24 months of randomization
the number of participants who suffer from severe TIA within 24 months of randomization
up to 24 months of randomization
the number of participants who suffer from all stroke or death during 30 days to 24 months
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
during 30 days to 24 months
the changes from baseline in mRS, national institutes of health stroke scale (NIHSS) and Barthel Index
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
at 7 days, 30 days, 6 months, 12 months and 24 months
the changes from baseline of cerebral blood flow (CBF) ratio in CT perfusion
Time Frame: at 24 months
the changes from baseline of CBF ratio in CT perfusion at 24 months
at 24 months
the number of participants who suffer from all kinds of adverse events related to surgery
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
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Feng Ling, MD, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2013

Primary Completion (Actual)

March 2, 2018

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

December 24, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XW125-S001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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