Non-acute Carotid Artery OcclusionRESCONCT06303414
Revascularization for Symptomatic Non-acute Carotid Artery Occlusion
An observational study of Non-acute Carotid Artery Occlusion, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-acute Carotid Artery Occlusion
- What is being tested?
- Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS) and Hybrid Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jun 2016to 30 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People diagnosed with non-acute carotid occlusion, fulfilled the above eligible criteria in tertiary medical centers in China additionally will be enrolled consecutively.
Who may be able to join
- Older than 18 years old;
- Sign the informed consent form;
- Carotid occlusion at least 24h;
- Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction;
- DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
- Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
- The optimal medical treatment for patients who still have ischemic symptoms;
- Routine DWI and ADC sequence examinations are performed before surgery no new infarction;
Who cannot join
- Intracranial arteriovenous malformation or aneurysm;
- Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
- Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L);
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
- Pregnant or in the perinatal period;
- Severe concomitant disease with poor prognosis (life expectancy < 3 years);
Show all 16Show fewer
- Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel;
- Allergy to iodine or radiographic contrast media;
- Concomitant vascular conditions precluding endovascular;
- Patients with large cerebral infarction within 2 weeks;
- History of ipsilateral vocal cord paralysis;
- Those with severe skin diseases who are expected to have difficulty healing the incision;
- Poor functional status before onset (mRS score 4-5 points).
- The area of infarction in the occluded vascular area exceeds half of the vascular supply area;
- Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments.
- Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100005
Tao Wang, MD, 18810302298, wangtao_dr@sina.com
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
Liqun Jiao, Dr., 13911224991, liqunjiao@sina.cn
About this study
The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.
Read the detailed description
Carotid artery occlusion is one of the primary causes of ischemic stroke. When the occlusion time exceeds 30 days, it is commonlly referred to as chronic carotid artery occlusion (CCAO), and patients with carotid artery occlusion over 24 hours are collectively referred as non-acute occlusion. Symptomatic non-acute occlusion patients with definite hemodynamic hypoperfusion still face a high risk of stroke recurrence under drug treatment, with recurrence rates reported to be between 12.3% and 22.7% within 2 years. Currently, the surgical methods for the treatment of carotid artery occlusion are mainly divided into extracranial-intracranial (EC-IC) bypass and recanalization treatment. Recanalization treatment includes CEA, endovascular intervention and hybrid surgery. While the Carotid Occlusion Surgery Study (COSS) and the recently published Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) failed to reveal the significant advantages of EC-IC bypass surgery over medical treatment for patients with symptomatic artery occlusion combined with hemodynamic insufficiency, recanalization treatment has been shown to be a promising treatment modality by case-control studies with small sample size. However, the short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. In addition, about half of non-acute occlusion patients have cognitive impairment, and the role of cerebral hemodynamics in cognitive impairment is still unclear. Therefore, the purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.
- Conditions
- Non-acute Carotid Artery Occlusion
- Being tested
- Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS), Hybrid Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Endarterectomy (CEA)Procedure or surgery
Carotid endarterectomy (CEA) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA, although the use of standard or eversion endarterectomy, and a shunt or patch, is left to the discretion of the surgeon.
Carotid Artery Stenting (CAS)Procedure or surgery
Carotid artery stenting (CAS) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 3 days before the CAS procedure and for 90 days after the procedure. They will receive a daily dose of 100 mg aspirin or 75 mg clopidogrel thereafter. For the CAS procedure, general anesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is advised for all patients who undergo CAS.
Hybrid SurgeryProcedure or surgery
Hybrid Surgery Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 5 days before the hybird surgery procedure. If they had stenting procedure, they will receive a daily dose of 100 mg aspirin and 75 mg clopidogrel thereafter. If not, they will take either 100mg aspirin or 75mg clopidogrel daily for life.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Endarterectomy (CEA) | Patients who are treated with CEA. Receives: Procedure: Carotid Endarterectomy (CEA) | |
| Carotid Artery Stenting (CAS) | Patients who are treated with CAS. Receives: Procedure: Carotid Artery Stenting (CAS) | |
| Hybrid Surgery | Patients who are treated with Hybrid Surgery. Receives: Procedure: Hybrid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months
Including TIA, minor stroke, moderate stroke, severe stroke, and fatal stroke
Measured: Up to 12 months after procedure
MMSE within 30 and 90 days after procedure
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.
Measured: 30 days and 90 days after procedure
MoCA scale within 30 and 90 days after procedure
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.The MoCA test is a one-page 30-point test administered in approximately 10 minutes. The MoCA assesses: Short term memory/ Visuospatial abilities/ Executive functions/ Attention, concentration and working memory/ Language/ Orientation to time and place.
Measured: 30 days and 90 days after procedure
Secondary outcomes (8)
Technical success rate
Defined as the target vessel residual stenosis less than 30% by CTA
Measured: Up to 24 hours after procedure
Procedural success rate
Defines as the residual stenosis of the target vessel is less than 30% by CTA, and free of peri-procedural complications(includes cranial nerve injury, cardiac arrest, anaphylaxis, failure to recanalize blood vessels, distal embolism events, massive blood loss during operation, and residual thrombosis in the stent after operation)
Measured: Up to 24 hours after procedure
Any stroke within 30 days, 90 days and 12 months after procedure
Any stroke within 30 days, 90 days and 12 months
Measured: Within 30 days, 90 days and 12 months post-procedure
Death within 30 days, 90 days and 12 months after procedure
Death within 30 days, 90 days and 12 months
Measured: Within30 days, 90 days and 12 months post-procedure
Cranial nerve injury
Number of participants who suffered from cranial nerve injury
Measured: Within 30 days and 90 days post-procedure
Carotid artery or internal carotid artery reocclusion
Number of participants who suffered from carotid artery or internal aryery rereocclusion (> 99%) detected by ultrasonography, CTA, MRA or DSA
Measured: Within 30 days, 90 days and 12 months post-procedure
Functional outcome
Functional outcome indicated by NIHSS (National Institutes of Health Stroke Scale: 0-42; 0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 moderate/severe stroke 21-42 = severe stroke ) or mRS (modified Rankin Scale: 0-6; 0-No symptoms at all. 1-No significant disability despite symptoms; able to carry out all usual duties and activities. 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3-Moderate disability; requiring some help, but able to walk without assistance. 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6-Dead.)
Measured: Within 30 days and 90 days post-procedure
Other major complications
Other major complications, such as myocardial infarction, pulmonary infection, postoperative bleeding, peri-procedural embolism, arterial dissection, vascular perforation, in-stent thrombus, post-procedural hyperperfusion syndrome, procedure related low perfusion infarction, etc.
Measured: Within 30 days, 90 days and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start17 Jun 2016
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303414
- Sponsor's protocol ID
- RESCO
- Acronym
- RESCO
- Status last verified
- Jun 2016
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please contact the PI
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization for Symptomatic Non-acute Carotid Artery Occlusion
- ClinicalTrials.gov ID
- NCT06303414
- Acronym / sponsor ID
- RESCO / RESCO
- Conditions
- Non-acute Carotid Artery Occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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 short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.
Detailed description
Carotid artery occlusion is one of the primary causes of ischemic stroke. When the occlusion time exceeds 30 days, it is commonlly referred to as chronic carotid artery occlusion (CCAO), and patients with carotid artery occlusion over 24 hours are collectively referred as non-acute occlusion. Symptomatic non-acute occlusion patients with definite hemodynamic hypoperfusion still face a high risk of stroke recurrence under drug treatment, with recurrence rates reported to be between 12.3% and 22.7% within 2 years. Currently, the surgical methods for the treatment of carotid artery occlusion are mainly divided into extracranial-intracranial (EC-IC) bypass and recanalization treatment. Recanalization treatment includes CEA, endovascular intervention and hybrid surgery. While the Carotid Occlusion Surgery Study (COSS) and the recently published Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) failed to reveal the significant advantages of EC-IC bypass surgery over medical treatment for patients with symptomatic artery occlusion combined with hemodynamic insufficiency, recanalization treatment has been shown to be a promising treatment modality by case-control studies with small sample size. However, the short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. In addition, about half of non-acute occlusion patients have cognitive impairment, and the role of cerebral hemodynamics in cognitive impairment is still unclear. Therefore, the purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy (CEA) | – | Procedure: Carotid Endarterectomy (CEA)Patients who are treated with CEA. |
| Carotid Artery Stenting (CAS) | – | Procedure: Carotid Artery Stenting (CAS)Patients who are treated with CAS. |
| Hybrid Surgery | – | Procedure: Hybrid SurgeryPatients who are treated with Hybrid Surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People diagnosed with non-acute carotid occlusion, fulfilled the above eligible criteria in tertiary medical centers in China additionally will be enrolled consecutively.
Key inclusion criteria (8 listed)
- Older than 18 years old;
- Sign the informed consent form;
- Carotid occlusion at least 24h;
- Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction;
- DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
Key exclusion criteria (16 listed)
- Intracranial arteriovenous malformation or aneurysm;
- Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
- Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L);
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
- Pregnant or in the perinatal period;
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 |
|---|---|---|
| Carotid Endarterectomy (CEA)Carotid endarterectomy (CEA) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA, although the use of standard or eversion endarterectomy, and a shunt or patch, is left to the discretion of the surgeon. | Procedure or surgery | Carotid Endarterectomy (CEA) |
| Carotid Artery Stenting (CAS)Carotid artery stenting (CAS) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 3 days before the CAS procedure and for 90 days after the procedure. They will receive a daily dose of 100 mg aspirin or 75 mg clopidogrel thereafter. For the CAS procedure, general anesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is advised for all patients who undergo CAS. | Procedure or surgery | Carotid Artery Stenting (CAS) |
| Hybrid SurgeryHybrid Surgery Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 5 days before the hybird surgery procedure. If they had stenting procedure, they will receive a daily dose of 100 mg aspirin and 75 mg clopidogrel thereafter. If not, they will take either 100mg aspirin or 75mg clopidogrel daily for life. | Procedure or surgery | Hybrid Surgery |
Primary outcome
Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months
Time frame: Up to 12 months after procedure
Including TIA, minor stroke, moderate stroke, severe stroke, and fatal stroke
MMSE within 30 and 90 days after procedure
Time frame: 30 days and 90 days after procedure
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.
MoCA scale within 30 and 90 days after procedure
Time frame: 30 days and 90 days after procedure
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.The MoCA test is a one-page 30-point test administered in approximately 10 minutes. The MoCA assesses: Short term memory/ Visuospatial abilities/ Executive functions/ Attention, concentration and working memory/ Language/ Orientation to time and place.
8 secondary outcomes
Technical success rate
Time frame: Up to 24 hours after procedure
Procedural success rate
Time frame: Up to 24 hours after procedure
Any stroke within 30 days, 90 days and 12 months after procedure
Time frame: Within 30 days, 90 days and 12 months post-procedure
Death within 30 days, 90 days and 12 months after procedure
Time frame: Within30 days, 90 days and 12 months post-procedure
Cranial nerve injury
Time frame: Within 30 days and 90 days post-procedure
Carotid artery or internal carotid artery reocclusion
Time frame: Within 30 days, 90 days and 12 months post-procedure
Functional outcome
Time frame: Within 30 days and 90 days post-procedure
Other major complications
Time frame: Within 30 days, 90 days and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Please contact the PI
Related trials for Non-acute Carotid Artery Occlusion
Not yet recruiting
Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion
Non-acute Carotid Artery Occlusion, Cognitive Impairment
RecruitingObservational study
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Aneurysm, Dissection
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-acute Carotid Artery Occlusion, run by Xuanwu Hospital, Beijing at 2 sites 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months (time frame: Up to 12 months after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024.