<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224209</url>
  </required_header>
  <id_info>
    <org_study_id>BTH-STEP</org_study_id>
    <nct_id>NCT02224209</nct_id>
  </id_info>
  <brief_title>Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis</brief_title>
  <acronym>STEP</acronym>
  <official_title>Comparison of Staged Angioplasty v.s. Routine Single-stage Stenting (CAS) in the Treatment of Patients With Carotid Artery Stenosis at High Risk of Hyperperfusion (STEP）: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of staged carotid&#xD;
      angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with&#xD;
      carotid artery stenosis at high hyperperfusion risk in peri-procedural period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Data Quality&#xD;
&#xD;
           Before the initiation of the study sites, Cerebrovascular Disease Center of Beijing&#xD;
           Tiantan Hospital will verify whether the investigators are qualified, inspect the study&#xD;
           site's facilities, and inform the investigators of their responsibilities, as well as&#xD;
           how to correctly and completely fill related documents. Through investigator training&#xD;
           sessions, the investigators and their teams will understand the trial protocol, CRF and&#xD;
           trial process, etc. Then start-up visit at each site will be initiated.&#xD;
&#xD;
           Trial monitors will pay start-up visit to the site, and pay the first inspection visit&#xD;
           as soon as possible after the screening/randomization of the first patient. Afterwards,&#xD;
           the monitors will pay inspection visits regularly until the trial visits end. They need&#xD;
           to directly refer to source data to verify the accurate of CRF filling and conduct&#xD;
           inspection/audits.&#xD;
&#xD;
           Data entered into the CRF shall be subject to examination of internal consistency&#xD;
           (within known classification and scope), external inspection (data are consistent with&#xD;
           the patient's other known data) and trend consistency (data changes do not exceed the&#xD;
           allowable range. For example, excess weight loss prompts changes in dietary status). The&#xD;
           contents of trial database include data collected by each site, abnormal data and&#xD;
           delayed data in progress tracking.&#xD;
&#xD;
        2. File Data&#xD;
&#xD;
           Data entered into the CRF must be able to be verified by source data, or directly&#xD;
           entered into the CRF. In this case, the data in the CRF can be regarded as source data,&#xD;
           and used for subsequent data confirmation. Required data of all patients' continued&#xD;
           treatment shall also be routinely recorded in their medical records. The site's&#xD;
           investigators shall clearly make patients' medical records that the patient is&#xD;
           participating in a clinical trial, and also require any other medical staff for&#xD;
           treatment of the patient to contact the trial contact persons before treatment. To this&#xD;
           end, the investigators shall provide their contact information. If a patient preserves&#xD;
           his/her medical records on his/her own, the study site shall preserve a copy of all&#xD;
           trial-related data. Unless related data or information is directly recorded in the CRF,&#xD;
           all research data must be recorded in patients' medical records (or research documents),&#xD;
           and entered into the CRF as early as possible. Source data to be verified and primary&#xD;
           documents used for such purpose must be preserved. Patients' research documents and all&#xD;
           source data shall be preserved until a notice for destruction is received from the&#xD;
           sponsor.&#xD;
&#xD;
        3. Statistical Method and Sample Size&#xD;
&#xD;
           3.1 Statistical Analysis&#xD;
&#xD;
           This study is powered on the primary endpoint of hyperperfusion syndrome (HPS) rate at&#xD;
           30 days post CAS procedure. Superiority analysis will be performed using a two-sample&#xD;
           t-test at a two-sided 5% alpha level. All secondary endpoints will be descriptively&#xD;
           compared between the two treatment arms.&#xD;
&#xD;
           All analyses will be performed on the Per-Protocol (PP) population. The PP population&#xD;
           will consist of patients who have received the treatment per randomization without major&#xD;
           protocol deviations.&#xD;
&#xD;
           X2 test is adopted for statistical analysis of two groups of results, supplemented by&#xD;
           compliance with the protocol and actual treatment analysis. The following confounding&#xD;
           factors will be considered in the analysis to determine the effect of different preset&#xD;
           confounding factors on prognosis:&#xD;
&#xD;
             -  Age;&#xD;
&#xD;
             -  Sex;&#xD;
&#xD;
             -  Blood pressure;&#xD;
&#xD;
             -  Degree, location, diameter and length of lesion stenosis;&#xD;
&#xD;
             -  Cerebrovascular collateral compensatory conditions;&#xD;
&#xD;
             -  Cerebral hemodynamics of the culprit side;&#xD;
&#xD;
             -  Cerebrovascular reserve or cerebrovascular autoregulation status of the culprit&#xD;
                side;&#xD;
&#xD;
             -  Diameter and pressure of balloon for stage-1 balloon angioplasty;&#xD;
&#xD;
             -  Carotid angioplasty experience of the operating site or doctor.&#xD;
&#xD;
           Appropriate methods will be employed to summarize and analyze patients' baseline&#xD;
           characteristics, safety and other indicators during the trial (including treatment&#xD;
           interruption/termination, lifestyle assessment, concomitant medication, etc.).&#xD;
           Multi-variant method is employed to analyze the effect of demographics and other factors&#xD;
           on primary results. All details of statistical analysis are shown in the separate&#xD;
           'Statistical Analysis Plan'(SAP).&#xD;
&#xD;
           3.2 Sample Size&#xD;
&#xD;
           The sample size calculation for the primary endpoint of HPS rate 30 days post CAS&#xD;
           procedure is based on the following assumptions:&#xD;
&#xD;
           Two-tailed superiority test a = 0.05 Power = 90% Randomization ratio is 1 (staged&#xD;
           angioplasty arm): 1 (routine single-stage CAS arm) The rate of HPS rate was expected to&#xD;
           be 0.16 per subject during the procedure in the regular CAS arm for high hyperperfusion&#xD;
           risk patients based on previous studies.&#xD;
&#xD;
           The rate of HPS rate was presume to be 0.02 per subject during the procedure in the&#xD;
           staged CAS arm for high hyperperfusion risk patients depended on the study by Yoshimura,&#xD;
           Kyung Mi Lee and us.&#xD;
&#xD;
           A total of 150 subjects were estimated to be required. Given the above assumptions, a&#xD;
           sample size of 150 (75 Staged CAS: 75 regular CAS) will be required. To account for an&#xD;
           estimated 5% dropout rate, approximately 158 patients will be enrolled. Of these 158&#xD;
           patients, 79 will be randomized to the Staged CAS arm and 79 will be randomized to the&#xD;
           regular CAS arm.&#xD;
&#xD;
           The sample size calculation was performed using SAS software, version 9.3 (SAS&#xD;
           Institute).&#xD;
&#xD;
        4. Collection of data during the procedure&#xD;
&#xD;
             -  Nerve function evaluation&#xD;
&#xD;
             -  NIHSS&#xD;
&#xD;
             -  mRS&#xD;
&#xD;
             -  Blood pressure&#xD;
&#xD;
             -  TCD&#xD;
&#xD;
             -  Laboratory examination&#xD;
&#xD;
             -  CT, MR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral hyperperfusion syndrome or cerebral hemorrhage</measure>
    <time_frame>Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.</time_frame>
    <description>Staged angioplasty arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.&#xD;
Regular single-stage CAS arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after CAS procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure.</measure>
    <time_frame>within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis &lt; 70%).</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure.</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure.</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarchtion (MI)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major non-stroke hemorrhage (eg. Epidural hemorrhage, intradural hemorrhage, or other major systemic bleedings)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death at 30 days post procedure</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stoke resulting in deformity</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any stroke or death</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">158</enrollment>
  <condition>Carotid Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>Staged angioplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Abbott EPD systems (Accunet/Emboshield), a balloon, stent&#xD;
Method of stage-1 angioplasty&#xD;
The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device; Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis &lt;70%.&#xD;
Method of stage-2:&#xD;
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is &lt;30%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine single-stage CAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using a balloon, stent&#xD;
Routine stenting procedure:&#xD;
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is &lt;30%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abbott EPD systems (Accunet/Emboshield), a balloon, stent</intervention_name>
    <description>Standard method of endovascular interventional treatment:&#xD;
Method of stage-1 angioplasty&#xD;
The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device;&#xD;
Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis &lt;70%.&#xD;
Method of stage-2:&#xD;
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);&#xD;
Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;&#xD;
After the placement of stent, the angioplasty is a success when residual stenosis is &lt;30%.</description>
    <arm_group_label>Staged angioplasty</arm_group_label>
    <other_name>Abbott Stent System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>a balloon, stent</intervention_name>
    <description>Routine stenting procedure:&#xD;
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);&#xD;
Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;&#xD;
After the placement of stent, the angioplasty is a success when residual stenosis is &lt;30%.</description>
    <arm_group_label>Routine single-stage CAS</arm_group_label>
    <other_name>Abbott Stent System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be 40~80 years of age&#xD;
&#xD;
          -  Patient with symptomatic carotid stenosis (defined as stroke/TIA of the patient within&#xD;
             90 days while he/she is taking at least one antithrombotic drug or under other&#xD;
             intervention on vascular risk factors like hypertension or hyperlipidemia)&#xD;
&#xD;
          -  DSA shows percent carotid stenosis≥90% (quantification of the stenosis according to&#xD;
             NASCET method); or near occlusion&#xD;
&#xD;
          -  Angiogram shows insufficient collateral circulation in the culprit vessel surrounding&#xD;
             area:&#xD;
&#xD;
               1. Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel&#xD;
                  surrounding area, and&#xD;
&#xD;
               2. DSA shows collateral circulation assessment &lt; 2, and&#xD;
&#xD;
               3. MRI cerebral imaging shows hemodynamic ischemic lesion&#xD;
&#xD;
          -  CT perfusion imaging shows cerebral blood flow of the culprit side is of 20% lower&#xD;
             than the other lateral brain&#xD;
&#xD;
          -  Lesion length at the narrowest part &lt; 25mm&#xD;
&#xD;
        Note: Grading of angiographic collateral circulation&#xD;
&#xD;
          -  Grade 0: No collateral circulation in the area dominated by the culprit vessel&#xD;
&#xD;
          -  Grade 1: Slow collateral circulation in the surrounding areas, but filling defects&#xD;
             exist&#xD;
&#xD;
          -  Grade 2: Fast collateral circulation, but some areas still have filling defects&#xD;
&#xD;
          -  Grade 3: Collateral circulation is slow, but complete filling can be seen in the vein&#xD;
             at a late stage&#xD;
&#xD;
          -  Grade 4: Complete and fast collateral circulation, without any filling defect&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diffusive stenosis of the cerebral artery&#xD;
&#xD;
          -  MRI cerebral imaging shows perforating artery occlusion&#xD;
&#xD;
          -  Cerebral hemorrhage at the culprit vessel surrounding area within 6 weeks; potential&#xD;
             thrombus from the heart&#xD;
&#xD;
          -  Subsequent cerebral tumor, cerebral aneurysm, or arteriovenous abnormality&#xD;
&#xD;
          -  Known contraindication to heparin, aspirin, ticlopidine, a aesthetic, and contrast;&#xD;
             blood hemoglobin &lt; 10g/dl, blood platelet &lt; 100000&#xD;
&#xD;
          -  Severe nerve dysfunction in the culprit vessel surrounding area after a cerebral&#xD;
             infarction (mRS≥3)&#xD;
&#xD;
          -  INR &gt; 1.5 (irreversible), uncorrectable bleeding risk factors, life expectancy &lt; 1&#xD;
             year&#xD;
&#xD;
          -  Women in pregnant or breast feeding&#xD;
&#xD;
          -  Committee adjudicating the inclusion criteria finds the patient is unsuitable for the&#xD;
             staged angioplasty for carotid artery stenosis&#xD;
&#xD;
          -  Unsuccessful placement of proximal or distal EPD during the procedure&#xD;
&#xD;
          -  The target vessel angle≧45&#xD;
&#xD;
          -  Participate in other clinical trials within three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongrong Miao, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Tian Tan Hospital, Capital Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yongjun Wang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Tian Tan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tian Tan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yongjun Wang, M.D.</last_name>
      <phone>13911172565</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>November 14, 2014</last_update_submitted>
  <last_update_submitted_qc>November 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Zhongrong Miao</investigator_full_name>
    <investigator_title>Director of Department of Intervention</investigator_title>
  </responsible_party>
  <keyword>Carotid artery stenosis</keyword>
  <keyword>High risk of hyperperfusion</keyword>
  <keyword>Staged angioplasty</keyword>
  <keyword>Routine single-stage stenting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224209
org study id: BTH-STEP
nct id: NCT02224209
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and safety of staged carotid
      angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with
      carotid artery stenosis at high hyperperfusion risk in peri-procedural period.
1. Data Quality

           Before the initiation of the study sites, Cerebrovascular Disease Center of Beijing
           Tiantan Hospital will verify whether the investigators are qualified, inspect the study
           site's facilities, and inform the investigators of their responsibilities, as well as
           how to correctly and completely fill related documents. Through investigator training
           sessions, the investigators and their teams will understand the trial protocol, CRF and
           trial process, etc. Then start-up visit at each site will be initiated.

           Trial monitors will pay start-up visit to the site, and pay the first inspection visit
           as soon as possible after the screening/randomization of the first patient. Afterwards,
           the monitors will pay inspection visits regularly until the trial visits end. They need
           to directly refer to source data to verify the accurate of CRF filling and conduct
           inspection/audits.

           Data entered into the CRF shall be subject to examination of internal consistency
           (within known classification and scope), external inspection (data are consistent with
           the patient's other known data) and trend consistency (data changes do not exceed the
           allowable range. For example, excess weight loss prompts changes in dietary status). The
           contents of trial database include data collected by each site, abnormal data and
           delayed data in progress tracking.

        2. File Data

           Data entered into the CRF must be able to be verified by source data, or directly
           entered into the CRF. In this case, the data in the CRF can be regarded as source data,
           and used for subsequent data confirmation. Required data of all patients' continued
           treatment shall also be routinely recorded in their medical records. The site's
           investigators shall clearly make patients' medical records that the patient is
           participating in a clinical trial, and also require any other medical staff for
           treatment of the patient to contact the trial contact persons before treatment. To this
           end, the investigators shall provide their contact information. If a patient preserves
           his/her medical records on his/her own, the study site shall preserve a copy of all
           trial-related data. Unless related data or information is directly recorded in the CRF,
           all research data must be recorded in patients' medical records (or research documents),
           and entered into the CRF as early as possible. Source data to be verified and primary
           documents used for such purpose must be preserved. Patients' research documents and all
           source data shall be preserved until a notice for destruction is received from the
           sponsor.

        3. Statistical Method and Sample Size

           3.1 Statistical Analysis

           This study is powered on the primary endpoint of hyperperfusion syndrome (HPS) rate at
           30 days post CAS procedure. Superiority analysis will be performed using a two-sample
           t-test at a two-sided 5% alpha level. All secondary endpoints will be descriptively
           compared between the two treatment arms.

           All analyses will be performed on the Per-Protocol (PP) population. The PP population
           will consist of patients who have received the treatment per randomization without major
           protocol deviations.

           X2 test is adopted for statistical analysis of two groups of results, supplemented by
           compliance with the protocol and actual treatment analysis. The following confounding
           factors will be considered in the analysis to determine the effect of different preset
           confounding factors on prognosis:

             -  Age;

             -  Sex;

             -  Blood pressure;

             -  Degree, location, diameter and length of lesion stenosis;

             -  Cerebrovascular collateral compensatory conditions;

             -  Cerebral hemodynamics of the culprit side;

             -  Cerebrovascular reserve or cerebrovascular autoregulation status of the culprit
                side;

             -  Diameter and pressure of balloon for stage-1 balloon angioplasty;

             -  Carotid angioplasty experience of the operating site or doctor.

           Appropriate methods will be employed to summarize and analyze patients' baseline
           characteristics, safety and other indicators during the trial (including treatment
           interruption/termination, lifestyle assessment, concomitant medication, etc.).
           Multi-variant method is employed to analyze the effect of demographics and other factors
           on primary results. All details of statistical analysis are shown in the separate
           'Statistical Analysis Plan'(SAP).

           3.2 Sample Size

           The sample size calculation for the primary endpoint of HPS rate 30 days post CAS
           procedure is based on the following assumptions:

           Two-tailed superiority test a = 0.05 Power = 90% Randomization ratio is 1 (staged
           angioplasty arm): 1 (routine single-stage CAS arm) The rate of HPS rate was expected to
           be 0.16 per subject during the procedure in the regular CAS arm for high hyperperfusion
           risk patients based on previous studies.

           The rate of HPS rate was presume to be 0.02 per subject during the procedure in the
           staged CAS arm for high hyperperfusion risk patients depended on the study by Yoshimura,
           Kyung Mi Lee and us.

           A total of 150 subjects were estimated to be required. Given the above assumptions, a
           sample size of 150 (75 Staged CAS: 75 regular CAS) will be required. To account for an
           estimated 5% dropout rate, approximately 158 patients will be enrolled. Of these 158
           patients, 79 will be randomized to the Staged CAS arm and 79 will be randomized to the
           regular CAS arm.

           The sample size calculation was performed using SAS software, version 9.3 (SAS
           Institute).

        4. Collection of data during the procedure

             -  Nerve function evaluation

             -  NIHSS

             -  mRS

             -  Blood pressure

             -  TCD

             -  Laboratory examination

             -  CT, MR
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cerebral hyperperfusion syndrome or cerebral hemorrhage
time frame: Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.
description: Staged angioplasty arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.
Regular single-stage CAS arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after CAS procedure
measure: Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure.
time frame: within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure
measure: Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis < 70%).
time frame: one year
measure: Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure.
time frame: one year
measure: Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure.
time frame: one year
measure: Myocardial infarchtion (MI)
time frame: one year
measure: Major non-stroke hemorrhage (eg. Epidural hemorrhage, intradural hemorrhage, or other major systemic bleedings)
time frame: one year
measure: Death at 30 days post procedure
time frame: one year
measure: Stoke resulting in deformity
time frame: one year
measure: Any stroke or death
time frame: one year
arm group label: Staged angioplasty
arm group type: Experimental
description: Using Abbott EPD systems (Accunet/Emboshield), a balloon, stent
Method of stage-1 angioplasty
The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device; Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.
Method of stage-2:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
arm group label: Routine single-stage CAS
arm group type: Active Comparator
description: Using a balloon, stent
Routine stenting procedure:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
intervention type: Device
intervention name: Abbott EPD systems (Accunet/Emboshield), a balloon, stent
description: Standard method of endovascular interventional treatment:
Method of stage-1 angioplasty
The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device;
Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.
Method of stage-2:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
arm group label: Staged angioplasty
other name: Abbott Stent System
intervention type: Device
intervention name: a balloon, stent
description: Routine stenting procedure:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
arm group label: Routine single-stage CAS
other name: Abbott Stent System
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhongrong Miao, M.D.
role: Study Director
affiliation: Beijing Tian Tan Hospital, Capital Medical University
last name: Yongjun Wang, M.D.
role: Study Director
affiliation: Beijing Tian Tan Hospital
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Zhongrong Miao
investigator title: Director of Department of Intervention
mesh term: Carotid Stenosis
mesh term: Constriction, Pathologic