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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Xuanwu Hospital, Beijing
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT01758614
First received: December 24, 2012
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Carotid Artery Occlusion
Middle Cerebral Artery Occlusion
Stroke
Procedure: bypass surgery
Drug: Aspirin
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Carotid and Middle Cerebral Artery Occlusion Surgery Study

Resource links provided by NLM:


Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:
  • the number of participants who suffer from stroke or death after EC-IC bypass surgery or medical therapy [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
    The number of participants who suffer from all stroke or death within 30 days after EC-IC bypass surgery or medical therapy

  • the number of participants who suffer from ipsilateral ischemic stroke [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    the number of participants who suffer from ipsilateral ischemic stroke within 24 months of randomization


Secondary Outcome Measures:
  • the number of participants who suffer from severe transit ischemic attack (TIA) [ Time Frame: up to 24 months of randomization ] [ Designated as safety issue: No ]
    the number of participants who suffer from severe TIA within 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 ] [ Designated as safety issue: No ]
    the number of participants who suffer from all stroke or death 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 ] [ Designated as safety issue: No ]
    the changes from baseline in mRS, NIHSS and Barthel Index 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 ] [ Designated as safety issue: No ]
    the changes from baseline of CBF ratio in CT perfusion at 24 months

  • the number of participants who suffer from all kinds of adverse events related to surgery [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 330
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: Aspirin
all participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day
Other Name: Aspirin 100mg per day or clopidogrel 75mg per day
Drug: Clopidogrel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758614

Contacts
Contact: Liqun Jiao, MD 010-83198836 ext +86 jiaoliqun@gmail.com
Contact: Yan Ma, MD 010-83198990 ext +86 leavesyan@sina.com

Locations
China, Beijing
Department of neurosurgery, Xuanwu hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Liqun Jiao, MD    010-83198836 ext +86    jiaoliqun@gmail.com   
Contact: Yan Ma, MD    010-83198990 ext +86    leavesyan@sina.com   
Sub-Investigator: Yanfei Chen, MD         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Feng Ling, MD Xuanwu Hospital, Beijing
  More Information

Publications:

Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT01758614     History of Changes
Other Study ID Numbers: XW125-S001
Study First Received: December 24, 2012
Last Updated: December 31, 2012
Health Authority: China: Ministry of Health

Keywords provided by Xuanwu Hospital, Beijing:
carotid artery occlusion
middle cerebral artery occlusion
EC-IC bypass surgery
stroke

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Arterial Occlusive Diseases
Infarction, Middle Cerebral Artery
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Stroke
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014