Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion

January 30, 2024 updated by: First Affiliated Hospital of Wannan Medical College

Study of Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion--- A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (RESCUE END-LOW)

Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score >5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RESCUE END-LOW is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 272 patients (age ≥ 18 years) in a late window (>24 hours) with a minor stroke (NIHSS <6) who experienced an END and the imaging evidence of an occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive best medical management alone the other group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish the efficacy of EVT in a late window for patients with LVO and a minor stroke who have experienced an END. The study consists of seven visits including the day of randomization, 24 hours after randomization, 48 hours, 72 hours, 7 days or discharge, and 30 and 90 days. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The primary endpoint is the rate of modified Rankin's scale (mRS) 0-2 at 90 days. The trial is anticipated to last from December 2023 to December 2025 with 272 subjects recruited form about 30 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Yijishan Hospital, Wannan Medical College.

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China
        • Recruiting
        • Fuyang People's Hospital
        • Contact:
          • Youmeng Wang, Dr
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Contact:
      • Huainan, Anhui, China
        • Recruiting
        • The First Hospital of ANHUI University of Science & Technology
        • Contact:
          • Tao Wang, Dr
      • Huangshan, Anhui, China
        • Recruiting
        • Huangshan City People's Hospital
        • Contact:
      • Suzhou, Anhui, China
        • Recruiting
        • Wan Bei General Hospital of Wanbei Coal power Group
        • Contact:
          • Benxiao Wang, MD
      • Wuhu, Anhui, China, 241000
        • Recruiting
        • The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
        • Contact:
        • Contact:
    • Hubei
      • Xiangyang, Hubei, China
        • Recruiting
        • Xiangyang No.1 People's Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

General Inclusion Criteria：

  • Age ≥ 18 years；
  • Presenting with symptoms consistent with an AIS and the initial NIHSS score <6 points；
  • Symptom progression within 7 days of first onset；
  • Randomization can be finished > 24 hours of stroke onset (stroke onset time is defined as last known well time)；
  • Symptom progression to randomization time ≤ 24 hours；
  • NIHSS score before randomization ≥ 6 points；
  • Informed consent signed.

Specific Neuroimaging Inclusion Criteria

  • CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
  • The progression of symptoms is caused by the recurrence of cerebrovascular diseases in the same vascular region, or the pathogenesis is caused by reduced blood flow perfusion;
  • NCCT ASPECTS before randomization ≥ 6 CTP or MRP assessment shows low perfusion in the target vessel area (Tmax>6S ≥ 70ml), and meets the following criteria: core infarction volume is less than 50ml, mismatch rate is greater than or equal to 1.2, and mismatch volume is greater than 10ml.

Exclusion Criteria:

  • Pre-stroke mRS score >1;
  • Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
  • The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery;
  • Severe stenosis or occlusion of multiple blood vessels;
  • Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations;
  • Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage;
  • Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month;
  • Known hemorrhagic tendency (including but not limited to): Baseline platelet count <40×109/L; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) > 2 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment) Severe heart, liver, kidney function damage or other severe late stage diseases of the system;
  • Known allergies to treatment related drugs such as iodine contrast agents, etc; Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
  • Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
  • Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l);
  • Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
  • The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
  • Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
  • Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular therapy

Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.

In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.
Procedure: Endovascular therapy

Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.

In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.

Other Names:
  • EVT group
Active Comparator: Best medical management
Patients in this group will receive best medical management alone. All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
Procedure: Endovascular therapy

Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.

In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.

Other Names:
  • EVT group
Drug: Best medical management
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate
Other Names:
  • Best medical management group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day good clinical outcome
Time Frame: 90±7 days after randomization
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
90±7 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofunctional deficit defined as modified Rankin Scale (mRS)
Time Frame: 90±7 days after randomization

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead
90±7 days after randomization
90-day clinical outcome
Time Frame: 90±7 days after randomization
mRS 0-3 outcome
90±7 days after randomization
Change of infarct volume from baseline to 7 days
Time Frame: baseline, 7 days after randomization
The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10-6mm2/s or on CTP image with rCBF<30%
baseline, 7 days after randomization
All-cause mortality rate
Time Frame: 90±7 days after randomization
All-cause mortality rate at 90±7 days
90±7 days after randomization
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Time Frame: within 24±6 hours after randomization

Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:

4 points total NIHSS at the time of diagnosis compared to immediately before worsening.

2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.

Absence of alternative explanation for deterioration.
within 24±6 hours after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Time Frame: within 24±6 hours after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
within 24±6 hours after randomization

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Wannan Medical College

Collaborators

The First Affiliated Hospital of Anhui Medical University

Investigators

  • Principal Investigator: Zhiming Zhou, PhD, The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
  • Principal Investigator: Kai Wang, PhD, The First Affiliated Hospital of Anhui Medical 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)

January 4, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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