Revascularization for Symptomatic Non-acute Carotid Artery Occlusion (RESCO)

March 4, 2024 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

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, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University.
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Older than 18 years old;
  2. Sign the informed consent form;
  3. Carotid occlusion at least 24h;
  4. 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;
  5. DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
  6. Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
  7. The optimal medical treatment for patients who still have ischemic symptoms;
  8. Routine DWI and ADC sequence examinations are performed before surgery no new infarction;

Exclusion Criteria:

  1. Intracranial arteriovenous malformation or aneurysm;
  2. Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
  3. Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L);
  4. Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
  5. Pregnant or in the perinatal period;
  6. Severe concomitant disease with poor prognosis (life expectancy < 3 years);
  7. Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel;
  8. Allergy to iodine or radiographic contrast media;
  9. Concomitant vascular conditions precluding endovascular;
  10. Patients with large cerebral infarction within 2 weeks;
  11. History of ipsilateral vocal cord paralysis;
  12. Those with severe skin diseases who are expected to have difficulty healing the incision;
  13. Poor functional status before onset (mRS score 4-5 points).
  14. The area of infarction in the occluded vascular area exceeds half of the vascular supply area;
  15. Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments.
  16. 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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Carotid Endarterectomy (CEA)
Patients who are treated with CEA.
Procedure: 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.
Carotid Artery Stenting (CAS)
Patients who are treated with CAS.
Procedure: 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.
Hybrid Surgery
Patients who are treated with Hybrid Surgery.
Procedure: Hybrid 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 12 months after procedure
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.
30 days and 90 days after procedure
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.
30 days and 90 days after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: Up to 24 hours after procedure
Defined as the target vessel residual stenosis less than 30% by CTA
Up to 24 hours after procedure
Procedural success rate
Time Frame: Up to 24 hours after procedure
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)
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
Any stroke within 30 days, 90 days and 12 months
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
Death within 30 days, 90 days and 12 months
Within30 days, 90 days and 12 months post-procedure
Cranial nerve injury
Time Frame: Within 30 days and 90 days post-procedure
Number of participants who suffered from cranial nerve injury
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
Number of participants who suffered from carotid artery or internal aryery rereocclusion (> 99%) detected by ultrasonography, CTA, MRA or DSA
Within 30 days, 90 days and 12 months post-procedure
Functional outcome
Time Frame: Within 30 days and 90 days post-procedure
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.)
Within 30 days and 90 days post-procedure
Other major complications
Time Frame: Within 30 days, 90 days and 12 months post-procedure
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.
Within 30 days, 90 days and 12 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RESCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Please contact the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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