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Acute Ischemic StrokeNCT05719688

Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

A study testing Mechanical thrombectomy in people with Acute Ischemic Stroke, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Mechanical thrombectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
18 sitesChina
Study dates
16 Dec 2022to 24 May 2024
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

  • Age 18-85
  • Within 8 hours of the onset of stroke symptoms
  • There are clinical signs and symptoms consistent with acute ischemic stroke
  • Imaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of CT or DWI image < 6, infarct volume ≥70ml or infarct area > 1/3MCA)
  • Patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the M1/M2 segment of the middle cerebral artery or the A1/A2 segment of the anterior cerebral artery without clear contraindications
  • 6 points ≤NIHSS score < 30 points
  • Informed consent is signed by the patient or her legal guardian

Who cannot join

  • Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel
  • mRS ≥ 2 before stroke
  • Pregnant Or Lactating Women
  • Hemorrhagic cerebrovascular history within 3 months
  • Refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg)
  • Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10∧9/L
Show all 13Show fewer
  • Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L
  • Patients with any of the following exclusion criteria were not eligible to participate in this study
  • Preoperative CT or MRI showed bleeding symptoms
  • CT or MRI shows intracranial mass or intracranial tumor requiring surgical treatment
  • Angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery
  • Angiography revealed simultaneous acute obstruction of both carotid systems
  • Participate in other drug or device clinical trials within 28 days prior to screening visit

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • The first people's hospital of changzhou

    Changzhou, Jiangsu, 213000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang, 314000

  • Lishui Municipal Central Hospital

    Lishui, Zhejiang, 323499

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200000

  • Zhangjiagang First People's Hospital

    Suzhou, Jiangsu, 215000

  • The Second People's Hospital of Wuxi

    Wuxi, Jiangsu, 214000

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441100

  • Xiangyang First People's Hospital

    Xiangyang, Hubei, 441100

  • Xianyang Hospital of Yan 'an University

    Xianyang, Shanxi, 712000

  • The affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Prospective, Multicenter, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the experiment, 200 subjects were selected and randomly divided into the experimental group and the control group 1:1. According to the information of the group, corresponding devices were used to receive endovascular therapy and the results were evaluated.

Read the detailed description

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the trial, 200 subjects with acute ischemic stroke who met the inclusion criteria and did not meet any exclusion criteria were randomly divided into the test group and the control group at 1:1, and received endovascular therapy with corresponding instruments according to the information of the group and evaluated the results

Being tested
Mechanical thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Mechanical thrombectomyDevice

    Treatment of ischemic stroke patients with Mechanical thrombectomy

Study groups in NCT05719688
Study groupRoleWhat they receive
Mechanical thrombectomy:Thrombectomy systemExperimentalSubjects will be treated with Thrombectomy system,Thrombectomy system is an intraarterial thrombectomy removal device that can be re-inserted into the sheath to restore blood flow by removing blood clots in occluded vessels.
Receives: Device: Mechanical thrombectomy
Intracranial thrombectomy stent :Solitaire FR Revascularization DeviceActive comparatorSubjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular

What is being measured

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

  1. Immediate postoperative target vessel recanalization (mTICI≥2b) rate

    According to 《the recommendations of the Chinese Guidelines for Stroke Prevention and Treatment》 , the therapeutic goal of mechanical thrombectomy is to achieve reperfusion of mTICI≥2b, so as to achieve the best possible functional outcome for patients. Therefore, we selected immediate postoperative target vessel recanalization (mTICI≥2b) rate as the primary efficacy endpoint.

    Measured: Immediately after surgery

Secondary outcomes (6)

  1. The time from puncture to recanalization

    The time from onset to recanalization will affect the prognosis of patients, and shorter recanalization time will bring better prognostic effect. Therefore, we chose the time from puncture to recanalization to compare the opening efficiency of the two groups of instruments.

    Measured: immediately after surgery

  2. The number of thrombectomy

    The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the number of thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.

    Measured: immediately after surgery

  3. the rate of successful vascular recirculation after the first thrombectomy

    The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the rate of successful vascular recirculation after the first thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.

    Measured: immediately after surgery

  4. NIHSS Score

    The Assessment of Neurological Deficits (NIHSS score) is a well-established and widely accepted scale for evaluating neurological deficits in stroke patients. Neurological function evaluation (NIHSS score) at one day after endovascular therapy is helpful to predict clinical outcome at 90 days after surgery. A score of 3 is usually considered as the limit. A score of 3 or less indicates a mild stroke, a score of 3-10 is a moderate stroke, and a score of more than 10 is a severe stroke.

    Measured: 24hours and 7days after surgery

  5. Proportion of patients with an mRS Score of 0-2 at 90 days after surgery

    MRS Score, also known as modified Rankin score scale, is a scale used to evaluate the recovery state of neurological function in stroke patients. There are seven levels, level 0: completely asymptomatic. Level 1: Despite symptoms, the patient has no apparent disability and can perform all regular work and activities. Level 2: Mildly disabled, unable to perform all work and activities, but able to handle personal matters without assistance from others. Level 3: moderately disabled, requiring assistance, to walking without assistance. Level 4: Severely disabled, unable to walk without assistance, unable to care for their own needs. Level 5: Severely disabled, bedridden, incontinent, in need of constant care, and in need of multiple round-the-clock attention. Level 6: Dead .The proportion of subjects with mRS Score of 0-2 at 90 days after surgery was selected as the basis for judging the prognosis of subjects.

    Measured: 3 mouths after surgery

  6. Performance evaluation of the device

    Device performance evaluation can help to evaluate the maneuverability of research devices in clinical application.Including the ability of the instrument to reach the lesion, the ability of the instrument to release and deploy smoothly, and the difficulty of the instrument to withdraw

    Measured: immediately after surgery

Timeline

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

  1. First posted9 Feb 2023
  2. Study start16 Dec 2022
  3. Primary completion31 Oct 2023
  4. Study completion24 May 2024

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05719688
Sponsor's protocol ID
CRD01
Status last verified
Jun 2025
First submitted
20 Nov 2022
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical thrombectomy in people with Acute Ischemic Stroke, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 18 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 13 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: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immediate postoperative target vessel recanalization (mTICI≥2b) rate (time frame: Immediately after surgery). 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 NCT05719688.

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 1 Jul 2025.

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