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

Acute Ischemic Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995757
• Other study ID #: 2016-GATOR-01-A
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: September 22, 2020

Study information

• Verified date: July 2021
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: September 22, 2020
• Est. primary completion date: July 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Device:
• Stent Retriever
Stent Retriever for acute ischemic stroke

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai City

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Recanalization Rate	Defined as modified treatment in cerebral infarction (mTICI) = 2b	immediate post-thrombectomy (t-0) and no later than 3 hours' post-procedure (t-3)
Secondary	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.	90± 14 days' post-treatment
Secondary	Time from puncture to mTICI=2b	Time from puncture to mTICI=2b	immediate post-thrombectomy (t-0)
Secondary	The NIHSS score at 30H post-treatment	The NIHSS score at 30H post-treatment	30± 6 hours' post-treatment
Secondary	Symptomatic intracranial hemorrhage(sICH) within 30H post-treatment	Any intracranial hemorrhage judged by CT(or MRI) with neurological symptoms	30±6 hours' post-treatment
Secondary	Death within 90D post-treatment	Any cause death within 90D post-treatment	90± 14 days' post-treatment
Secondary	AE/SAE within 90D post-treatment	Any cause AE/SAEs within 90D post-treatment	90± 14 days' post-treatment
Secondary	Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment	Stentretriever/procedure/stroke related AE/SAEs within 90D post-treatment	90± 14 days' post-treatment