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

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Stent Retriever

• Registration Number: NCT04995757
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-21
• Primary Completion: 2020-07-05
• Study Completion: 2020-09-22
• Status Verified: 2021-07
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Last Update Submitted: 2021-07-30
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

• 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.
• 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:

    1. Severe intracranial tortuosity
    2. Severe intracranial vasospasm, unresponsive to pharmacotherapy.
    3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solitaire FR	Stent Retriever	-
MicroPort NeuroTech Stentretriever	Stent Retriever	-

Primary Outcome Measures

Name	Time	Method
Successful Recanalization Rate	immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)	Defined as modified treatment in cerebral infarction (mTICI) ≥ 2b

Secondary Outcome Measures

Name	Time	Method
Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment	30±6 hours' post-treatment	Any intracranial hemorrhage judged by CT(or MRI) with neurological symptoms
Time from puncture to mTICI≥2b	immediate post-thrombectomy (t-0)	Time from puncture to mTICI≥2b
The NIHSS score at 30H post-treatment	30± 6 hours' post-treatment	The NIHSS score at 30H post-treatment
AE/SAE within 90D post-treatment	90± 14 days' post-treatment	Any cause AE/SAEs within 90D post-treatment
mRS at D90	90± 14 days' post-treatment	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.
Death within 90D post-treatment	90± 14 days' post-treatment	Any cause death within 90D post-treatment
Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment	90± 14 days' post-treatment	Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai City, China