Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke

NCT05101668 | Terminated

• 1 other identifier: SINOMED ADPAT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief Summary

A prospective, multicenter, single-arm objective performance criteria trial to investigate the safety and efficacy of SINOMED ADPAT for Recanalization Therapy in acute large-vessel occlusive stroke.

Conditions

Aspiration; Acute Ischemic Stroke; Large-vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• Instant recanalization rate of target vessel after operation

  Instant recanalization rate (mTICI 2b-3) of target vessel after operation

  Last aspiration

Secondary Outcomes (12)

• Instant recanalization rate of target vessel after the first aspiration

  First aspiration

• The recanalization time of the target vessel blood flow

  Procedure time (femoral artery puncture to recanalization)

• The improvement of the postoperative NIHSS score the improvement of the postoperative NIHSS score

  Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge

• Proportion of good neurological function (mRS 0-2)

  90 days

• The success rate of device

  Intraoperative

Study Arms (1)

Intracranial Thrombosis Aspiration Catheter

EXPERIMENTAL

Intracranial Thrombosis Aspiration Catheter, product of Sinomed Neurovita Technology Inc.

Device: Intracranial Thrombosis Aspiration Catheter

Interventions

Intracranial Thrombosis Aspiration Catheter DEVICE

Direct Aspiration

Intracranial Thrombosis Aspiration Catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years and ≤ 85 years;
• Acute ischemic stroke, patients with anterior / posterior circulation vessel occlusion (intracranial segment of internal carotid artery or M1 or M2 segment of middle cerebral artery) confirmed by digital subtraction angiography (DSA);
• Premorbid modified Rankin Scale(mRS)\<2 and Pre-operation NIHSS score ≥6;
• The patients should receive endovascular treatment within 24 hours:
• If the treatment could happen within 6 hours, the patient should have an CT or MR
• If the treatment could happen 6-24 hours, the patient should have an CT or magnetic resonance (MR), have an ASPECTS ≥ 6 points. If immediate CT perfusion imaging or MR perfusion imaging is feasible, CT perfusion (CTP) or magnetic resonance perfusion (MRP) should be performed at the same time to assist in the evaluation of the infarct core.
• Written informed consent obtained from patient or patient's legally authorized representative.

You may not qualify if:

• Large (more than one-third of the MCA) regions of clear hypodensity on the baseline neuroimaging or significant mass effect with midline shift;
• Any type of intracranial hemorrhage or subarachnoid hemorrhage (only microbleeds are allowed, or judge from surgeon's clinical experience) by neuroimaging;
• Proven Simultaneous acute occlusion of both carotid artery systems, and Proven tandem lesion of simultaneous occlusion of intracranial and extracranial vessels by neuroimaging;
• Occlusion of the common carotid artery,and known or suspected chronic occlusion of target vessel;
• Patients with consciousness disorder with posterior circulation vascular occlusion, NIHSS score is 3 points (1a=3);
• Proven intracranial artery occlusion due to arterial dissection or arteritis by neuroimaging;
• Arterial tortuosity and other problems that would prevent the device from reaching the target vessel;
• Known to have one or more of the following allergies/resistances or contraindications: antiplatelet drugs/anticoagulant drugs/contrast agents and/or anesthetics;
• Known allergies to medical devices and related products (allergy to materials such as nickel-titanium metal or its alloys);
• Active bleeding or known bleeding tendency (such as: anticoagulant therapy or coagulation dysfunction before surgery, international normalized ratio (INR)\>3.0);
• Baseline platelet counts\<40×10\^9/L;
• Severe heart, liver or kidney failure and other serious or terminal illness;
• Accompanied by ST-segment elevation myocardial infarction or severe infection (endocarditis or sepsis);
• Hypertension that cannot be controlled after treatment (Baseline blood pressure\>185/110 mmHg);
• Baseline blood glucose \< 2.7 or \> 22.2 mmol/L. after treatment;

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead

Study Sites (6)

Qingwu Yang

Chongqing, 400037, China

Location

LIUZHOU People's Hospital

Liuchow, 545026, China

Location

Jinzhao Liu

Pujiang, 457001, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, 430000, China

Location

Xiangtan Central Hospital

Xiangtan, 411199, China

Location

Xiang Yang No.1 Peoples Hospital

Xiangyang, 441011, China

Location

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 Officials

• Qingwu Yang, M.D/Ph.D

  The Second Affiliated Hospital of Army Medical University

  PRINCIPAL INVESTIGATOR

• Yimin Liu, M.D/Ph.D

  Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single-arm objective performance criteria

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: October 8, 2021
• Primary Completion: July 18, 2022
• Study Completion: August 17, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (6)