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

NCT04995757 | Completed

• 1 other identifier: 2016-GATOR-01-A
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• mRS at D90

  90± 14 days' post-treatment

• Time from puncture to mTICI≥2b

  immediate post-thrombectomy (t-0)

• The NIHSS score at 30H post-treatment

  30± 6 hours' post-treatment

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

  30±6 hours' post-treatment

• Death within 90D post-treatment

  90± 14 days' post-treatment

Study Arms (2)

MicroPort NeuroTech Stentretriever

EXPERIMENTAL

Device: Stent Retriever

Solitaire FR

ACTIVE COMPARATOR

Device: Stent Retriever

Interventions

Stent Retriever DEVICE

Stent Retriever for acute ischemic stroke

MicroPort NeuroTech Stentretriever; Solitaire FR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Functional dependence prior to stroke onset, defined as a pre-stroke modified Rankin Scale (mRS) score of ≥2.
• \. Subject's baseline NIHSS score \<2 or \>25.
• \. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history.
• \. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor.
• \. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
• \. Subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an International Normalized Ratio (INR) \>3.
• \. Subject's baseline platelet count is \<30\*10\^9/L.
• \. Subject's baseline glucose is \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.2 mmol/L).
• \. Renal failure, as defined by a serum creatinine \>3.0 mg/dL (264 µmol/L) \[NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels\].
• \. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mmHg) \[if the blood pressure can be successfully reduced and maintained at the acceptable level, using medication, the patient can be enrolled\].
• \. Subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia.
• \. 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.
• \. Subject is generally unsuitable for endovascular intervention or anesthesia.
• \. Subject has had major surgery within the previous 30 days
• \. 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai City, China

Location

Related Publications (2)

• 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.

  PMID: 38070920 DERIVED

• 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.

  PMID: 36588884 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: March 21, 2018
• Primary Completion: July 5, 2020
• Study Completion: September 22, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-07

Locations

CN (1)