Carotid Artery OcclusionPhase 3CMOSSNCT01758614
The Carotid and Middle Cerebral Artery Occlusion Surgery Study
A Phase 3 study testing bypass surgery, Aspirin and Clopidogrel in people with Carotid Artery Occlusion and Middle Cerebral Artery Occlusion, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carotid Artery Occlusion, Middle Cerebral Artery Occlusion, Stroke
- What is being tested?
- bypass surgery, Aspirin and Clopidogrel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2013to 1 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of neurosurgery, Xuanwu hospital
Beijing, Beijing Municipality, 100053
About this study
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.
Read more
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.
Read the 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.
- Being tested
- bypass surgery, Aspirin, Clopidogrel
- Keywords
- carotid artery occlusion, middle cerebral artery occlusion, EC-IC bypass surgery, stroke
- Medical subject headings
- Infarction, Middle Cerebral Artery, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bypass surgeryProcedure or surgery
Also called EC-IC bypass surgery
all participants in this group will be performed EC-IC bypass surgery
AspirinDrug
Also called Aspirin 100mg per day or clopidogrel 75mg per day
all participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| bypass group | Experimental | all the participants in this group will be performed EC-IC bypass surgery Receives: Procedure: bypass surgery |
| medical group | Active comparator | all the participants in this group will be given medical therapy including aspirin 100mg per day or clopidogrel 75mg per day Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants who suffer from stroke or death after EC-IC bypass surgery or medical therapy
The number of participants who suffer from all stroke or death within 30 days after EC-IC bypass surgery or medical therapy
Measured: up to 30 days
the number of participants who suffer from ipsilateral ischemic stroke
the number of participants who suffer from ipsilateral ischemic stroke within 24 months of randomization
Measured: up to 24 months
Secondary outcomes (5)
the number of participants who suffer from severe transit ischemic attack (TIA)
the number of participants who suffer from severe TIA within 24 months of randomization
Measured: up to 24 months of randomization
the number of participants who suffer from all stroke or death during 30 days to 24 months
the number of participants who suffer from all stroke or death during 30 days to 24 months
Measured: during 30 days to 24 months
the changes from baseline in mRS, national institutes of health stroke scale (NIHSS) and Barthel Index
the changes from baseline in mRS, NIHSS and Barthel Index at 7 days, 30 days, 6 months, 12 months and 24 months
Measured: 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
the changes from baseline of CBF ratio in CT perfusion at 24 months
Measured: at 24 months
the number of participants who suffer from all kinds of adverse events related to surgery
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
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study start6 Jun 2013
- Primary completion2 Mar 2018
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ling, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758614
- Sponsor's protocol ID
- XW125-S001
- Acronym
- CMOSS
- Status last verified
- Nov 2021
- First submitted
- 24 Dec 2012
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Powers WJ, Clarke WR, Grubb RL Jr, Videen TO, Adams HP Jr, Derdeyn CP; COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610.
PubMed 22068990Carlson AP, Yonas H, Chang YF, Nemoto EM. Failure of cerebral hemodynamic selection in general or of specific positron emission tomography methodology?: Carotid Occlusion Surgery Study (COSS). Stroke. 2011 Dec;42(12):3637-9. doi: 10.1161/STROKEAHA.111.627745. Epub 2011 Sep 29.
PubMed 21960571Amin-Hanjani S, Barker FG 2nd, Charbel FT, Connolly ES Jr, Morcos JJ, Thompson BG; Cerebrovascular Section of the American Association of Neurological Surgeons; Congress of Neurological Surgeons. Extracranial-intracranial bypass for stroke-is this the end of the line or a bump in the road? Neurosurgery. 2012 Sep;71(3):557-61. doi: 10.1227/NEU.0b013e3182621488.
PubMed 22668888Grubb RL Jr, Derdeyn CP, Fritsch SM, Carpenter DA, Yundt KD, Videen TO, Spitznagel EL, Powers WJ. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998 Sep 23-30;280(12):1055-60. doi: 10.1001/jama.280.12.1055.
PubMed 9757852Waaijer A, van der Schaaf IC, Velthuis BK, Quist M, van Osch MJ, Vonken EP, van Leeuwen MS, Prokop M. Reproducibility of quantitative CT brain perfusion measurements in patients with symptomatic unilateral carotid artery stenosis. AJNR Am J Neuroradiol. 2007 May;28(5):927-32.
PubMed 17494672Wang T, Yang Y, Wang H, Liu D, Wang J, Luo J, Yang R, Li T, Gong H, Sun X, Derdeyn CP, Ma Y, Jiao L; CMOSS Investigators. CT Perfusion for Predicting Ischemic Stroke in Patients With Symptomatic Carotid or Middle Cerebral Artery Occlusion: A Post Hoc Analysis of the CMOSS Study. Stroke. 2025 Sep;56(9):2579-2587. doi: 10.1161/STROKEAHA.125.051352. Epub 2025 Jun 19.
PubMed 40534574Li X, Li Y, Wang T, Sun X, Lu G, Xu X, Yang R, Luo J, Bai X, Tong X, Gu Y, Wang J, Tong Z, Wang Y, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Chen T, Ma Y, Jiao L; CMOSS Investigators. Determining the Optimal Age for Extracranial-Intracranial Bypass Surgery: A Post Hoc Analysis of the CMOSS Randomized Trial. Stroke. 2025 Feb;56(2):362-370. doi: 10.1161/STROKEAHA.124.048766. Epub 2024 Dec 27.
PubMed 39727027Lu G, Wang T, Sun X, Yang R, Luo J, Tong X, Gu Y, Wang J, Tong Z, Kuai D, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Ma Y, Liu S, Jiao L; for CMOSS investigators. Qualifying Event and Recurrence of Ischemic Stroke in Symptomatic Artery Occlusion: A Post Hoc Analysis of CMOSS. J Am Heart Assoc. 2024 Jul 2;13(13):e034056. doi: 10.1161/JAHA.123.034056. Epub 2024 Jun 27.
PubMed 38934799Ma Y, Wang T, Wang H, Amin-Hanjani S, Tong X, Wang J, Tong Z, Kuai D, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Bai X, Powers WJ, Derdeyn CP, Wu Y, Ling F, Gu Y, Jiao L; CMOSS Investigators. Extracranial-Intracranial Bypass and Risk of Stroke and Death in Patients With Symptomatic Artery Occlusion: The CMOSS Randomized Clinical Trial. JAMA. 2023 Aug 22;330(8):704-714. doi: 10.1001/jama.2023.13390.
PubMed 37606672Ma Y, Gu Y, Tong X, Wang J, Kuai D, Wang D, Ren J, Duan L, Maimaiti A, Cai Y, Huang Y, Wang X, Cao Y, You C, Yu J, Jiao L, Ling F. The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial. Trials. 2016 Nov 16;17(1):544. doi: 10.1186/s13063-016-1600-1.
PubMed 27852286
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Carotid and Middle Cerebral Artery Occlusion Surgery Study
- ClinicalTrials.gov ID
- NCT01758614
- Acronym / sponsor ID
- CMOSS / XW125-S001
- Keywords
- carotid artery occlusion, middle cerebral artery occlusion, EC-IC bypass surgery, stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bypass group | Experimental | Procedure: bypass surgeryall the participants in this group will be performed EC-IC bypass surgery |
| medical group | Active comparator | Drug: Aspirin, Drug: Clopidogrelall the participants in this group will be given medical therapy including aspirin 100mg per day or clopidogrel 75mg per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bypass surgeryAlso: EC-IC bypass surgeryall participants in this group will be performed EC-IC bypass surgery | Procedure or surgery | bypass group |
| AspirinAlso: Aspirin 100mg per day or clopidogrel 75mg per dayall participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day | Drug | medical group |
| Clopidogrel | Drug | medical group |
Primary outcome
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
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
5 secondary outcomes
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 all stroke or death during 30 days to 24 months
Time frame: 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 of cerebral blood flow (CBF) ratio in CT perfusion
Time frame: at 24 months
the number of participants who suffer from all kinds of adverse events related to surgery
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Results publication: PubMed 22068990Powers WJ, Clarke WR, Grubb RL Jr, Videen TO, Adams HP Jr, Derdeyn CP; COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610.
- Results publication: PubMed 21960571Carlson AP, Yonas H, Chang YF, Nemoto EM. Failure of cerebral hemodynamic selection in general or of specific positron emission tomography methodology?: Carotid Occlusion Surgery Study (COSS). Stroke. 2011 Dec;42(12):3637-9. doi: 10.1161/STROKEAHA.111.627745. Epub 2011 Sep 29.
- Results publication: PubMed 22668888Amin-Hanjani S, Barker FG 2nd, Charbel FT, Connolly ES Jr, Morcos JJ, Thompson BG; Cerebrovascular Section of the American Association of Neurological Surgeons; Congress of Neurological Surgeons. Extracranial-intracranial bypass for stroke-is this the end of the line or a bump in the road? Neurosurgery. 2012 Sep;71(3):557-61. doi: 10.1227/NEU.0b013e3182621488.
- Results publication: PubMed 9757852Grubb RL Jr, Derdeyn CP, Fritsch SM, Carpenter DA, Yundt KD, Videen TO, Spitznagel EL, Powers WJ. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998 Sep 23-30;280(12):1055-60. doi: 10.1001/jama.280.12.1055.
- Results publication: PubMed 17494672Waaijer A, van der Schaaf IC, Velthuis BK, Quist M, van Osch MJ, Vonken EP, van Leeuwen MS, Prokop M. Reproducibility of quantitative CT brain perfusion measurements in patients with symptomatic unilateral carotid artery stenosis. AJNR Am J Neuroradiol. 2007 May;28(5):927-32.
- Derived from this study: PubMed 40534574Wang T, Yang Y, Wang H, Liu D, Wang J, Luo J, Yang R, Li T, Gong H, Sun X, Derdeyn CP, Ma Y, Jiao L; CMOSS Investigators. CT Perfusion for Predicting Ischemic Stroke in Patients With Symptomatic Carotid or Middle Cerebral Artery Occlusion: A Post Hoc Analysis of the CMOSS Study. Stroke. 2025 Sep;56(9):2579-2587. doi: 10.1161/STROKEAHA.125.051352. Epub 2025 Jun 19.
- Derived from this study: PubMed 39727027Li X, Li Y, Wang T, Sun X, Lu G, Xu X, Yang R, Luo J, Bai X, Tong X, Gu Y, Wang J, Tong Z, Wang Y, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Chen T, Ma Y, Jiao L; CMOSS Investigators. Determining the Optimal Age for Extracranial-Intracranial Bypass Surgery: A Post Hoc Analysis of the CMOSS Randomized Trial. Stroke. 2025 Feb;56(2):362-370. doi: 10.1161/STROKEAHA.124.048766. Epub 2024 Dec 27.
- Derived from this study: PubMed 38934799Lu G, Wang T, Sun X, Yang R, Luo J, Tong X, Gu Y, Wang J, Tong Z, Kuai D, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Ma Y, Liu S, Jiao L; for CMOSS investigators. Qualifying Event and Recurrence of Ischemic Stroke in Symptomatic Artery Occlusion: A Post Hoc Analysis of CMOSS. J Am Heart Assoc. 2024 Jul 2;13(13):e034056. doi: 10.1161/JAHA.123.034056. Epub 2024 Jun 27.
- Derived from this study: PubMed 37606672Ma Y, Wang T, Wang H, Amin-Hanjani S, Tong X, Wang J, Tong Z, Kuai D, Cai Y, Ren J, Wang D, Duan L, Maimaitili A, Hang C, Yu J, Bai X, Powers WJ, Derdeyn CP, Wu Y, Ling F, Gu Y, Jiao L; CMOSS Investigators. Extracranial-Intracranial Bypass and Risk of Stroke and Death in Patients With Symptomatic Artery Occlusion: The CMOSS Randomized Clinical Trial. JAMA. 2023 Aug 22;330(8):704-714. doi: 10.1001/jama.2023.13390.
- Derived from this study: PubMed 27852286Ma Y, Gu Y, Tong X, Wang J, Kuai D, Wang D, Ren J, Duan L, Maimaiti A, Cai Y, Huang Y, Wang X, Cao Y, You C, Yu J, Jiao L, Ling F. The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial. Trials. 2016 Nov 16;17(1):544. doi: 10.1186/s13063-016-1600-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Ling, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bypass surgery, Aspirin and Clopidogrel in people with Carotid Artery Occlusion and Middle Cerebral Artery Occlusion, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758614, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.