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CompletedNCT04995757Updated Aug 9, 2021

CAPTURE Registration Trial of the Thrombectomy System for the Treatment of Acute Ischemic Stroke.

An interventional study of Stent Retriever in Acute Ischemic Stroke, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-09.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2018, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
239
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

As this will be a pre-market registration trial, in which devices will be used in accordance with appropriately labeled indications, pre-study notifications and approval requests will be addressed with CFDA. All trial results will be shared with CFDA.

02

Conditions studied

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 239 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject must demonstrate clinical signs and symptoms that are attributable to the targeted lesion and are consistent with the diagnosis of acute ischemic stroke (AIS), as confirmed by a neuroradiologist (or equivalent expert), using appropriate imaging. Arterial occlusion of ICA, MCA-M1 or MCA-M2.
  • Female or male subject, who, at the time of consenting, is aged between 18 and 80 years, inclusive.
  • Within 6 hours of stroke symptom onset, subject must have undergone treatment initiation (vascular access through puncture or cut down).
  • Signed Informed Consent Form (ICF) completed by subject or subject's legal representative.

Exclusion criteria

Exclusion Criteria:

    1. Functional dependence prior to stroke onset, defined as a pre-stroke modified Rankin Scale (mRS) score of ≥2.
    1. Subject's baseline NIHSS score \<2 or >25.
    1. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history.
    1. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor.
    1. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
    1. Subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an International Normalized Ratio (INR) >3.
    1. Subject's baseline platelet count is \<30*10\^9/L.
    1. Subject's baseline glucose is \<50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.2 mmol/L).
    1. Renal failure, as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) [NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels].
    1. Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mmHg) [if the blood pressure can be successfully reduced and maintained at the acceptable level, using medication, the patient can be enrolled].
    1. Subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia.
    1. Subject has known allergy to nickel, cobalt chromium, tungsten, platinum or other metal that may be a component of a required medical device needed for treatment.
    1. Subject is generally unsuitable for endovascular intervention or anesthesia.
    1. Subject has had major surgery within the previous 30 days
    1. Subject is an active participant in another drug or device treatment trial for any disease state; or, subject is expected to start participation in another drug or device trial while enrolled in this protocol.
    1. Subject currently has infective endocarditis or other severe, active bacterial infection.
    1. Subject's life expectancy is less than 6 months.
    1. Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.

Imaging Exclusion Criteria:

    1. Subject has CT scan or MRI evidence of the following:

      • Significant mass effect with midline shift.
      • Evidence of intracranial tumor, except small meningioma.
      • Evidence of intracranial hemorrhage.
      • Evidence of internal carotid artery flow limiting dissection.
      • Suspected cerebral vasculitis.
      • Suspected aortic dissection.
      • Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) or clinical evidence of bilateral strokes or strokes in multiple territories.
    1. The presence of a large completed territorial infarction by non-contrast CT (NCCT), defined as an Alberta Stroke Program Early CT Score (ASPECTS) ≤5.
    1. Other unusual morphology or lesion that might interfere with device use, including but not limited to the following:

      • Carotid dissection
      • Vasculitis
      • Aortic dissection
      • Aneurysm
      • No transfemoral or alternative access, such as:

        1. Severe intracranial tortuosity
        2. Severe intracranial vasospasm, unresponsive to pharmacotherapy.
        3. Other anatomical or clinical conditions contraindicated for access.
    1. Anterior circulation strokes involving > 1/3 of the MCA territory, as determined by hypo-density on the baseline non-contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images.
    1. Thrombotic occlusion in the posterior circulation arteries (vertebral, basilar, etc.)
    1. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy device.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
239 participants (actual)

Study arms

  • Experimental
    MicroPort NeuroTech Stentretriever

    Device: Stent Retriever

  • Active comparator
    Solitaire FR

    Device: Stent Retriever

Interventions

  • DeviceStent Retriever

    Stent Retriever for acute ischemic stroke

06

What researchers measure

Primary outcomes

  1. Successful Recanalization Rate

    Defined as modified treatment in cerebral infarction (mTICI) ≥ 2b

    Time frame: immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)

Secondary outcomes

  1. mRS at D90

    The modified Rankin Scale (mRS), a combined clinical/functionality and secondary safety endpoint, reflects the degree of disability or dependence in activities of daily living among treated patients. Though listed and classified separately, in multiple publications, as a functionality or clinical endpoint and because of its prominent and unique value in stroke trials, mRS should be considered first among key safety parameters in subjects who complete the 90-day evaluation. A successful endpoint will be defined as follows: "at 90± 14 days' post-treatment, the frequency of mRS scores ≤2 or a post-treatment decrease in mRS score of ≥2, relative to the baseline determination". Patients who die, between thrombectomy initiation and 90-Days, will be given an mRS value of 6 in this analysis.

    Time frame: 90± 14 days' post-treatment

  2. Time from puncture to mTICI≥2b

    Time from puncture to mTICI≥2b

    Time frame: immediate post-thrombectomy (t-0)

  3. The NIHSS score at 30H post-treatment

    The NIHSS score at 30H post-treatment

    Time frame: 30± 6 hours' post-treatment

  4. Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment

    Any intracranial hemorrhage judged by CT(or MRI) with neurological symptoms

    Time frame: 30±6 hours' post-treatment

  5. Death within 90D post-treatment

    Any cause death within 90D post-treatment

    Time frame: 90± 14 days' post-treatment

  6. AE/SAE within 90D post-treatment

    Any cause AE/SAEs within 90D post-treatment

    Time frame: 90± 14 days' post-treatment

  7. Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment

    Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment

    Time frame: 90± 14 days' post-treatment

07

Study locations

1 site
  • Changhai Hospital
    Shanghai, Shanghai City, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04995757
Lead sponsor
Changhai Hospital
Responsible party
Jian-min Liu (Professor, Changhai Hospital) — Principal investigator
First posted
Aug 9, 2021
Start date
Mar 21, 2018
Primary completion
Jul 5, 2020
Completion
Sep 22, 2020
Last update
Aug 9, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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