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Carotid Artery StenosisPhase 4STEPNCT02224209

Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis

A Phase 4 study testing Abbott EPD systems (Accunet/Emboshield), a balloon, stent and a balloon, stent in people with Carotid Artery Stenosis, run by Beijing Tiantan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
Abbott EPD systems (Accunet/Emboshield), a balloon, stent and a balloon, stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteChina
Study dates
Nov 2014to Sep 2017
Phase
Phase 4
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be 40~80 years of age
  • Patient with symptomatic carotid stenosis (defined as stroke/TIA of the patient within 90 days while he/she is taking at least one antithrombotic drug or under other intervention on vascular risk factors like hypertension or hyperlipidemia)
  • DSA shows percent carotid stenosis≥90% (quantification of the stenosis according to NASCET method); or near occlusion
  • Angiogram shows insufficient collateral circulation in the culprit vessel surrounding area:
  • Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel surrounding area, and
  • DSA shows collateral circulation assessment < 2, and
Show all 15Show fewer
  • MRI cerebral imaging shows hemodynamic ischemic lesion
  • CT perfusion imaging shows cerebral blood flow of the culprit side is of 20% lower than the other lateral brain
  • Lesion length at the narrowest part < 25mm
  • Note: Grading of angiographic collateral circulation
  • Grade 0: No collateral circulation in the area dominated by the culprit vessel
  • Grade 1: Slow collateral circulation in the surrounding areas, but filling defects exist
  • Grade 2: Fast collateral circulation, but some areas still have filling defects
  • Grade 3: Collateral circulation is slow, but complete filling can be seen in the vein at a late stage
  • Grade 4: Complete and fast collateral circulation, without any filling defect

Who cannot join

  • Diffusive stenosis of the cerebral artery
  • MRI cerebral imaging shows perforating artery occlusion
  • Cerebral hemorrhage at the culprit vessel surrounding area within 6 weeks; potential thrombus from the heart
  • Subsequent cerebral tumor, cerebral aneurysm, or arteriovenous abnormality
  • Known contraindication to heparin, aspirin, ticlopidine, a aesthetic, and contrast; blood hemoglobin < 10g/dl, blood platelet < 100000
  • Severe nerve dysfunction in the culprit vessel surrounding area after a cerebral infarction (mRS≥3)
Show all 12Show fewer
  • INR > 1.5 (irreversible), uncorrectable bleeding risk factors, life expectancy < 1 year
  • Women in pregnant or breast feeding
  • Committee adjudicating the inclusion criteria finds the patient is unsuitable for the staged angioplasty for carotid artery stenosis
  • Unsuccessful placement of proximal or distal EPD during the procedure
  • The target vessel angle≧45
  • Participate in other clinical trials within three months

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Yongjun Wang, M.D., 13911172565

Other trials in China

About this study

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

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.

Read the detailed description
  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).
  1. Collection of data during the procedure
  • Nerve function evaluation
  • NIHSS
  • mRS
  • Blood pressure
  • TCD
  • Laboratory examination
  • CT, MR
Being tested
Abbott EPD systems (Accunet/Emboshield), a balloon, stent, a balloon, stent
Keywords
Carotid artery stenosis, High risk of hyperperfusion, Staged angioplasty, Routine single-stage stenting
Medical subject headings
Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott EPD systems (Accunet/Emboshield), a balloon, stentDevice

    Also called Abbott Stent System

    Standard method of endovascular interventional treatment:

    Method of stage-1 angioplasty

    1. 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;
    2. Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.

    Method of stage-2:

    1. The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
    2. Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
    3. After the placement of stent, the angioplasty is a success when residual stenosis is <30%.

  • a balloon, stentDevice

    Also called Abbott Stent System

    Routine stenting procedure:

    1. The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
    2. Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
    3. After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
Study groups in NCT02224209
Study groupRoleWhat they receive
Staged angioplastyExperimentalUsing 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%.
Receives: Device: Abbott EPD systems (Accunet/Emboshield), a balloon, stent
Routine single-stage CASActive comparatorUsing 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%.
Receives: Device: a balloon, stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebral hyperperfusion syndrome or cerebral hemorrhage

    • 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

    Measured: Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.

Secondary outcomes (9)

  1. Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure.

    Measured: within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure

  2. Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis < 70%).

    Measured: one year

  3. Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure.

    Measured: one year

  4. Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure.

    Measured: one year

  5. Myocardial infarchtion (MI)

    Measured: one year

  6. Major non-stroke hemorrhage (eg. Epidural hemorrhage, intradural hemorrhage, or other major systemic bleedings)

    Measured: one year

  7. Death at 30 days post procedure

    Measured: one year

  8. Stoke resulting in deformity

    Measured: one year

  9. Any stroke or death

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2016 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224209
Sponsor's protocol ID
BTH-STEP
Acronym
STEP
Status last verified
Nov 2014
First submitted
8 Aug 2014
Last updated
17 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Mo D, Jia B, Shi H, Sun Y, Liu Q, Fan C, Deng J, Yuan J, Wu W, Jiang C, Zhang G, Du H, Ma N, Gao F, Sun X, Song L, Liu L, Peng G, Wang Y, Wang Y, Miao Z; STEP Study Group. Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial. Stroke Vasc Neurol. 2021 Mar;6(1):95-102. doi: 10.1136/svn-2020-000391. Epub 2020 Sep 24.

    PubMed 32973113

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abbott EPD systems (Accunet/Emboshield), a balloon, stent and a balloon, stent in people with Carotid Artery Stenosis, run by Beijing Tiantan Hospital 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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Nov 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

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.). 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 NCT02224209, which also lists 1 linked publication.

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 17 Nov 2014.

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