Clinical trial NCT04995757: CAPTURE Registration Trial of the Thrombectomy System for the Treatment of Acute Ischemic Stroke.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful Recanalization Rate
timeFrame: immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)
Secondary outcomes:
measure: mRS at D90
timeFrame: 90± 14 days' post-treatment
measure: Time from puncture to mTICI≥2b
timeFrame: immediate post-thrombectomy (t-0)
measure: The NIHSS score at 30H post-treatment
timeFrame: 30± 6 hours' post-treatment
measure: Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment
timeFrame: 30±6 hours' post-treatment
measure: Death within 90D post-treatment
timeFrame: 90± 14 days' post-treatment
measure: AE/SAE within 90D post-treatment
timeFrame: 90± 14 days' post-treatment
measure: Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment
timeFrame: 90± 14 days' post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai City
Study officials:
References: