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Acute Ischemic StrokeNCT04995757

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

A study testing Stent Retriever in people with Acute Ischemic Stroke, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Stent Retriever
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
1 siteChina
Study dates
21 Mar 2018to 22 Sep 2020
Phase
Interventional
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. Functional dependence prior to stroke onset, defined as a pre-stroke modified Rankin Scale (mRS) score of ≥2.
  • 2. Subject's baseline NIHSS score <2 or >25.
  • 3. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history.
  • 4. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor.
  • 5. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
  • 6. Subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an International Normalized Ratio (INR) >3.
Show all 40Show fewer
  • 7. Subject's baseline platelet count is <30*10^9/L.
  • 8. Subject's baseline glucose is <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.2 mmol/L).
  • 9. 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].
  • 10. 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].
  • 11. Subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia.
  • 12. 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.
  • 13. Subject is generally unsuitable for endovascular intervention or anesthesia.
  • 14. Subject has had major surgery within the previous 30 days
  • 15. 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.
  • 16. Subject currently has infective endocarditis or other severe, active bacterial infection.
  • 17. Subject's life expectancy is less than 6 months.
  • 18. 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:
  • 19. 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.
  • 20. The presence of a large completed territorial infarction by non-contrast CT (NCCT), defined as an Alberta Stroke Program Early CT Score (ASPECTS) ≤5.
  • 21. 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:
  • Severe intracranial tortuosity
  • Severe intracranial vasospasm, unresponsive to pharmacotherapy.
  • Other anatomical or clinical conditions contraindicated for access.
  • 22. 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.
  • 23. Thrombotic occlusion in the posterior circulation arteries (vertebral, basilar, etc.)
  • 24. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy device.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, Shanghai City

Other trials in China

About this study

Official title: Prospective, Randomized, Controlled, Open Label, Single Blinded, All China, Multi-Center, Registration Trial of the Thrombectomy System for the Treatment of Acute Ischemic Stroke.

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.

Being tested
Stent Retriever
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Stent RetrieverDevice

    Stent Retriever for acute ischemic stroke

Study groups in NCT04995757
Study groupRoleWhat they receive
MicroPort NeuroTech StentretrieverExperimentalNot described
Receives: Device: Stent Retriever
Solitaire FRActive comparatorNot described
Receives: Device: Stent Retriever

What is being measured

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

  1. Successful Recanalization Rate

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

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

Secondary outcomes (7)

  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.

    Measured: 90± 14 days' post-treatment

  2. Time from puncture to mTICI≥2b

    Time from puncture to mTICI≥2b

    Measured: immediate post-thrombectomy (t-0)

  3. The NIHSS score at 30H post-treatment

    The NIHSS score at 30H post-treatment

    Measured: 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

    Measured: 30±6 hours' post-treatment

  5. Death within 90D post-treatment

    Any cause death within 90D post-treatment

    Measured: 90± 14 days' post-treatment

  6. AE/SAE within 90D post-treatment

    Any cause AE/SAEs within 90D post-treatment

    Measured: 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

    Measured: 90± 14 days' post-treatment

Timeline

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

  1. First posted9 Aug 2021
  2. Study start21 Mar 2018
  3. Primary completion5 Jul 2020
  4. Study completion22 Sep 2020

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995757
Sponsor's protocol ID
2016-GATOR-01-A
Status last verified
Jul 2021
First submitted
30 Jul 2021
Last updated
9 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li G, Sun Y, Liu T, Yang P, Peng Y, Chen W, Zhang L, Chu J, Kuai D, Wang Z, Wu W, Xu Y, Zhou B, Geng Y, Yin C, Li J, Wang M, Peng X, Xiao Y, Li M, Zhang X, Liu P, Wang N, Zhang Y. Predictive factors of poor outcome and mortality among anterior ischaemic stroke patients despite successful recanalisation in China: a secondary analysis of the CAPTURE trial. BMJ Open. 2023 Dec 9;13(12):e078917. doi: 10.1136/bmjopen-2023-078917.

    PubMed 38070920

  • Zhang Y, Liu P, Li Z, Peng Y, Chen W, Zhang L, Chu J, Kuai D, Chen Z, Wu W, Xu Y, Zhang Y, Zhou B, Geng Y, Yin C, Li J, Wang M, Zhai N, Peng X, Ji Z, Xiao Y, Zhu X, Cai X, Zhang L, Hong B, Xing P, Shen H, Zhang Y, Li M, Shang M, Liu J, Yang P. Endovascular treatment of acute ischemic stroke with a fully radiopaque retriever: A randomized controlled trial. Front Neurol. 2022 Dec 14;13:962987. doi: 10.3389/fneur.2022.962987. eCollection 2022.

    PubMed 36588884

Questions about this trial

What is this clinical trial studying?

A study testing Stent Retriever in people with Acute Ischemic Stroke, run by Changhai 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 4 inclusion and 40 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: finished, as of the sponsor's last update on 9 Aug 2021. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Recanalization Rate (time frame: immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)). 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 NCT04995757, which also lists 2 linked publications.

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 9 Aug 2021.

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