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AspirationNCT05101668

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

A study testing Intracranial Thrombosis Aspiration Catheter in people with Aspiration and Acute Ischemic Stroke, run by Sinomed Neurovita Technology Inc. at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Intracranial Thrombosis Aspiration Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
6 sitesChina
Study dates
8 Oct 2021to 17 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Life expectancy less than 3 months;
  • Women who are pregnant or planning to pregnancy during half a year by taking medical history);
  • Dementia or psychiatric disease that would confound the neurological or functional evaluations;
  • Current participation in another drug or device research;
  • Other special situations which the researchers believe to be not suitable for enrollment.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Qingwu Yang

    Chongqing, 400037

  • LIUZHOU People's Hospital

    Liuzhou, 545026

  • Jinzhao Liu

    Pujiang, 457001

  • Zhongnan Hospital of Wuhan University

    Wuhan, 430000

  • Xiangtan Central Hospital

    Xiangtan, 411199

  • Xiang Yang No.1 Peoples Hospital

    Xiangyang, 441011

Other trials in China

About this study

Official title: 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.

Read the 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

Being tested
Intracranial Thrombosis Aspiration Catheter
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracranial Thrombosis Aspiration CatheterDevice

    Direct Aspiration

Study groups in NCT05101668
Study groupRoleWhat they receive
Intracranial Thrombosis Aspiration CatheterExperimentalIntracranial Thrombosis Aspiration Catheter, product of Sinomed Neurovita Technology Inc.
Receives: Device: Intracranial Thrombosis Aspiration Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Instant recanalization rate of target vessel after operation

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

    Measured: Last aspiration

Secondary outcomes (12)

  1. Instant recanalization rate of target vessel after the first aspiration

    Instant recanalization rate (mTICI 2b-3) of target vessel after the first aspiration

    Measured: First aspiration

  2. The recanalization time of the target vessel blood flow

    The recanalization (mTICI 2b-3) time of the target vessel blood flow

    Measured: Procedure time (femoral artery puncture to recanalization)

  3. The improvement of the postoperative NIHSS score the improvement of the postoperative NIHSS score

    NIH Stroke Scale/Score (NIHSS)：Calculates the NIH Stroke Scale for quantifying stroke severity.

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

  4. Proportion of good neurological function (mRS 0-2)

    The modified Rankin Scale/Score (mRS) : scores of 0 to 2 were defined as good neurological function (treatment success)

    Measured: 90 days

  5. The success rate of device

    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.

    Measured: Intraoperative

  6. The success rate of operation

    The success of recanalization after the final treatment (mTICI 2b-3, allowing the use of rescue therapy)

    Measured: End of Procedure

  7. The incidence of symptomatic intracranial hemorrhage

    Through Heidelberg Bleeding Classification to evaluate the intracranial hemorrhage (National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points)

    Measured: 24(-6/+24) hours

  8. All-cause death and stroke-related mortality

    All-cause death and stroke-related mortality

    Measured: 90 days

  9. The rate of Stroke recurrence

    The existence of clear imaging evidence to confirm that the target vessel is occluded again, which leads to an ischemic stroke event.

    Measured: 90 days

  10. Procedure-related complications

    Procedure-related complications: including arterial rupture, arterial dissection, distal thromboembolism, vascular puncture site complications, etc

    Measured: Intraoperative

  11. Adverse events and serious adverse events

    Any adverse events and serious adverse events are associated with clinical trials in human

    Measured: During the clinical trials

  12. The rate of device defection

    Device defection

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start8 Oct 2021
  3. Primary completion18 Jul 2022
  4. Study completion17 Aug 2022

Why it stopped: According to the Medical Device Classification Catalogue issued by the NMPA in 2022, the registration path of intracranial aspiration catheter is clinical evaluation, and clinical trials are not required.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, multicenter, single-arm objective performance criteria
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101668
Sponsor's protocol ID
SINOMED ADPAT
Status last verified
Apr 2023
First submitted
20 Oct 2021
Last updated
27 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intracranial Thrombosis Aspiration Catheter in people with Aspiration and Acute Ischemic Stroke, run by Sinomed Neurovita Technology Inc. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: According to the Medical Device Classification Catalogue issued by the NMPA in 2022, the registration path of intracranial aspiration catheter is clinical evaluation, and clinical trials are not required.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Instant recanalization rate of target vessel after operation (time frame: Last aspiration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

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