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

April 25, 2023 updated by: Sinomed Neurovita Technology Inc.

A Prospective, Multi-center, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in Treatment of Acute Large-vessel Occlusive Stroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study plans to recruit 164 patients with acute intracranial large-vessel occlusion within 24 hours time window. The Primary endpoint is the instant recanalization rate of target vessel after operation. Secondary efficacy endpoints will include: 1) immediate recanalization rate of the first pass of aspiration; 2) the recanalization time of the target vessel blood flow; 3) the improvement of the postoperative NIHSS score; 4) the ratio of good neurological function (mRS 0-2 points) at 90 days; 5) the success rate of device; 6) the success rate of operation; 7) The proportion of rescue therapy. Safety endpoints will include: 1) the incidence of symptomatic intracranial hemorrhage within 24 hours after operation; 2) all-cause death and stroke-related mortality at 90 days; 3) stroke recurrence rate within 90 days after operation; 4) surgery-related complications; 5) adverse events; 6) serious adverse events; 7) Device defection rate

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400037
        • Qingwu Yang
      • Liuzhou, China, 545026
        • Liuzhou People's Hospital
      • Puyang, China, 457001
        • Jinzhao Liu
      • Wuhan, China, 430000
        • Zhongnan Hospital of Wuhan University
      • Xiangtan, China, 411199
        • Xiangtan Central Hospital
      • Xiangyang, China, 441011
        • Xiang Yang NO.1 Peoples Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥ 18 years and ≤ 85 years;
  2. 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);
  3. Premorbid modified Rankin Scale(mRS)<2 and Pre-operation NIHSS score ≥6;

  4. The patients should receive endovascular treatment within 24 hours:

    1. If the treatment could happen within 6 hours, the patient should have an CT or MR
    2. 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.
  5. Written informed consent obtained from patient or patient's legally authorized representative.

Exclusion Criteria:

  1. Large (more than one-third of the MCA) regions of clear hypodensity on the baseline neuroimaging or significant mass effect with midline shift;
  2. Any type of intracranial hemorrhage or subarachnoid hemorrhage (only microbleeds are allowed, or judge from surgeon's clinical experience) by neuroimaging;
  3. Proven Simultaneous acute occlusion of both carotid artery systems, and Proven tandem lesion of simultaneous occlusion of intracranial and extracranial vessels by neuroimaging;
  4. Occlusion of the common carotid artery,and known or suspected chronic occlusion of target vessel;
  5. Patients with consciousness disorder with posterior circulation vascular occlusion, NIHSS score is 3 points (1a=3);
  6. Proven intracranial artery occlusion due to arterial dissection or arteritis by neuroimaging;
  7. Arterial tortuosity and other problems that would prevent the device from reaching the target vessel;
  8. Known to have one or more of the following allergies/resistances or contraindications: antiplatelet drugs/anticoagulant drugs/contrast agents and/or anesthetics;
  9. Known allergies to medical devices and related products (allergy to materials such as nickel-titanium metal or its alloys);
  10. Active bleeding or known bleeding tendency (such as: anticoagulant therapy or coagulation dysfunction before surgery, international normalized ratio (INR)>3.0);
  11. Baseline platelet counts<40×10^9/L;
  12. Severe heart, liver or kidney failure and other serious or terminal illness;
  13. Accompanied by ST-segment elevation myocardial infarction or severe infection (endocarditis or sepsis);
  14. Hypertension that cannot be controlled after treatment (Baseline blood pressure>185/110 mmHg);
  15. Baseline blood glucose < 2.7 or > 22.2 mmol/L. after treatment;
  16. Life expectancy less than 3 months;
  17. Women who are pregnant or planning to pregnancy during half a year by taking medical history);
  18. Dementia or psychiatric disease that would confound the neurological or functional evaluations;
  19. Current participation in another drug or device research;
  20. Other special situations which the researchers believe to be not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intracranial Thrombosis Aspiration Catheter
Intracranial Thrombosis Aspiration Catheter, product of Sinomed Neurovita Technology Inc.
Device: Intracranial Thrombosis Aspiration Catheter
Direct Aspiration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Instant recanalization rate of target vessel after operation
Time Frame: Last aspiration
Instant recanalization rate (mTICI 2b-3) of target vessel after operation
Last aspiration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Instant recanalization rate of target vessel after the first aspiration
Time Frame: First aspiration
Instant recanalization rate (mTICI 2b-3) of target vessel after the first aspiration
First aspiration
The recanalization time of the target vessel blood flow
Time Frame: Procedure time (femoral artery puncture to recanalization)
The recanalization (mTICI 2b-3) 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
Time Frame: Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge
NIH Stroke Scale/Score (NIHSS)：Calculates the NIH Stroke Scale for quantifying stroke severity.
Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge
Proportion of good neurological function (mRS 0-2)
Time Frame: 90 days
The modified Rankin Scale/Score (mRS) : scores of 0 to 2 were defined as good neurological function (treatment success)
90 days
The success rate of device
Time Frame: Intraoperative
The intracranial thrombus aspiration catheter was successfully delivered to the occluded segment of the blood vessel and then successfully released, and suction was performed, and the delivery system was successfully withdrawn.
Intraoperative
The success rate of operation
Time Frame: End of Procedure
The success of recanalization after the final treatment (mTICI 2b-3, allowing the use of rescue therapy)
End of Procedure
The incidence of symptomatic intracranial hemorrhage
Time Frame: 24(-6/+24) hours
Through Heidelberg Bleeding Classification to evaluate the intracranial hemorrhage (National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points)
24(-6/+24) hours
All-cause death and stroke-related mortality
Time Frame: 90 days
All-cause death and stroke-related mortality
90 days
The rate of Stroke recurrence
Time Frame: 90 days
The existence of clear imaging evidence to confirm that the target vessel is occluded again, which leads to an ischemic stroke event.
90 days
Procedure-related complications
Time Frame: Intraoperative
Procedure-related complications: including arterial rupture, arterial dissection, distal thromboembolism, vascular puncture site complications, etc
Intraoperative
Adverse events and serious adverse events
Time Frame: During the clinical trials
Any adverse events and serious adverse events are associated with clinical trials in human
During the clinical trials
The rate of device defection
Time Frame: Intraoperative
Device defection
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinomed Neurovita Technology Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qingwu Yang, M.D/Ph.D, The Second Affiliated Hospital of Army Medical University
  • Principal Investigator: Yimin Liu, M.D/Ph.D, Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SINOMED ADPAT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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