Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion

NCT05902000 | Unknown DMC

• 1 other identifier: WKJ-ZJ-2327
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b\_50) for acute anterior circulation tandem lesions within 24h of onset, can improve neurological functional outcomes(mRS≤2).
2. 2.To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b\_50) for acute anterior circulation tandem lesions within 24h of onset, can increase the risk of symptomatic intracranial hemorrhage.

Conditions

Thrombectomy; Tandem Occlusion; Stroke

Keywords

tandem occlusion; anterior circulation; stent implantation; balloon dilation; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Rate of functional independence

  Rate of functional independence defined as a modified Rankin Scale (mRS) score 0-2 at 90 (±7 days) (blind and independent evaluation) The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.

  at 90±7 days

• Rate of symptomatic intracranial hemorrhage

  Rate of symptomatic intracerebral hemorrhage at CT (Computerized Tomography) or MRI (Magnetic Resonance Imaging) at 36 hours (±12 hours) according to the Heidelberg classification (independent imaging core laboratory).

  at 36 hours (±12 hours)

Secondary Outcomes (13)

• The expanded treatment in cerebral infarction (eTICI) score

  at the end of the endovascular procedure

• Ipsilateral carotid residual stenosis rate

  at the end of the endovascular procedure

• The National Institutes of Health Stroke Scale (NIHSS) score

  at 36 hours (±12 hours)

• Proportion of NIHSS scores 0-1

  at 36 hours (±12 hours)

• Change in National Institutes of Health Stroke Scale (NIHSS) score

  at 36 hours (±12 hours)

Study Arms (2)

Thrombectomy + Carotid Stenting

EXPERIMENTAL

After emergency admission,intravenous thrombolysis will be administered if possible. Standard endovascular thrombectomy (EMT) and balloon angioplasty will be performed. The method of EMT and the order of endovascular treatment were selected by each center. After EMT and balloon angioplasty, patients with eTICI≥2b\_50 were maintained for more than 10 minutes for randomization. In the intervention arm, emergent carotid stenting will be performed. Standardized treatment with antiplatelet and other drugs will be given. A loading dose of antiplatelet agents (aspirin 300 mg and clopidogrel 300 mg) or Tirofiban was given as an intraoperative drug treatment to endovascular therapy prior to emergency balloon dilation or stenting. Intravenous sedation or general anesthesia will be permitted. Oral dual antiplatelet treatment for more than 1 month. Tirofiban is maintained for 24-48 hours, overlapping with oral antiplatelet for 4-6 hours, after excluding intracranial hemorrhage.

Device: Carotid Stenting; Procedure: Thrombectomy; Drug: Dual antiplatelet treatment; Drug: Intraoperative Drug Treatment

Thrombectomy alone

NO INTERVENTION

Intracranial thrombectomy alone（balloon dilation of the ipsilateral internal carotid artery if necessary）

Interventions

Carotid Stenting DEVICE

Emergent carotid stenting will be performed if the patient is randomized in the intervention arm. The order to treat (head first or neck first) the extracranial carotid artery lesion will be left to the interventionist discretion.

Thrombectomy + Carotid Stenting

Thrombectomy PROCEDURE

Intracranial thrombectomy is an endovascular procedure. In the experimental group, thrombectomy will be completed with extracranial carotid stenting.

Thrombectomy + Carotid Stenting

Dual antiplatelet treatment DRUG

Dual antiplatelet therapy is administered after 24 hours of imaging follow-up excluding intracranial hemorrhagic complications. Aspirin Enteric-coated Tablets (Bay Aspirin) 100mg once a night+Clopidogrel Sulfate Tablets (Plavix) 75mg once daily. If there is no contraindication, maintain for more than 1 month, then adjust the dosing regimen according to the guidelines.

Thrombectomy + Carotid Stenting

Intraoperative Drug Treatment DRUG

Tirofiban is used as an adjunct to endovascular therapy. The currently recommended dosing regimen is a combined intra-catheter arterial administration of a loading dose of 0.4 μg/(kg-min) for 30 min (total dose not to exceed 1 mg)， followed by intravenous pumping of 0.1μg/(kg-min) for 24-48h, and adjustment of dosing in conjunction with CT.

Thrombectomy + Carotid Stenting

Eligibility Criteria

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

You may qualify if:

• Age 18-85 years old;
• Acute ischemic stroke and the onset time within 24h;
• Pre-stroke mRS 0-1;
• NIHSS score of 6-30 before randomization;
• Completed randomization within 24h after stroke onset；
• Subjects are able to sign an informed consent in person or by the legal representative
• Satisfy one of the following criteria:①Within 6 hours of onset, imaging confirmed occlusion of the acute anterior circulation internal carotid artery or the M1 / M2 segment of the middle cerebral artery；②Within 6-16 hours of onset, imaging confirmed acute occlusion of anterior circulation internal carotid artery or M1 / M2 segment of middle cerebral artery followed by DAWN or DEFUSE-3 criteria；③In patients with 16 to 24 hours of onset, imaging confirmed intracranial occlusion of the acute anterior circulation internal carotid artery or M1 / M2 segment of the middle cerebral artery followed by DAWN criteria.
• Extracranial segment stenosis ≥70% or occlusion in tandem lesions.
• ASPECT score ≥ 6 points.
• eTICI≥2b\_50 after middle cerebral artery thrombectomy and extracranial balloon dilatation in 10min.

You may not qualify if:

• Participating in other clinical trials; 2.It is planned to carry out selective internal carotid artery stent implantation within 3 months; 3.Intracranial hemorrhage, subarachnoid hemorrhage within 3 months; previous brain tumor (with space-occupying effect).
• Parenchymal organ surgery or biopsy were performed last 1 month; Any active or recent bleeding (gastrointestinal, urinary, etc.); Parenchymal organ surgery and biopsy were performed last 1 month 5.Difficult to control hypertension: systolic blood pressure\> 185mmHg and/ or diastolic blood pressure\> 110mmHg.
• Severe active bleeding or known significant bleeding tendency: platelet count \<100X109/L; heparin within 48 hours before surgery, and APTT≥35s; oral warfarin, and INR\> 1.7; direct thrombin or factor Xa inhibitors, such as apixaban tablets, rivaroxaban tablets and dabigatran (patients with no history of abnormal coagulation or suspected abnormal coagulation function do not need laboratory results of INR or APTT before enrollment）.
• Severe heart, liver, kidney, and other organ insufficiencies (glomerular filtration rate \<30 ml/min or blood creatinine\> 220μmol/L(2.5mg/dl)).
• Patients occurred acute ischemic cerebral infarction within 48 hours after percutaneous coronary or cerebrovascular intervention or major surgery (if more than 48h, patients may be enrolled).
• \. The patient has a history of cerebral vasculitis with clear evidence; 10. Patients with pre-onset neurological or psychiatric disorders that affect the assessment of their condition 11.Women who are known to be pregnant or lactating. 12.Known severe allergy to contrast agents (except for mild rash allergy) 13.Expected survival time less than 1 year (such as combined malignancy, severe cardiopulmonary disease, etc.) 14.Patients unable to complete the follow up (e. g., no fixed residence, overseas patients, etc.).
• Imaging confirmed the posterior circulatory lesions.
• Midline displacement of the brain or brain herniation, ventricular occupancy
• New onset bilateral acute stroke or multiple intracranial macrovascular occlusions.
• Patients with vascular variants that are difficult to treat with endovascular therapy as displayed by CTA/MRA;
• The ipsilateral middle cerebral artery and anterior cerebral occlusion were combined.

Sponsors & Collaborators

• Xueli Cai: lead

Study Sites (1)

Lishui Municipal Hospital

Lishui, Zhejiang, China

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Li X Cai

  Lishui Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li X Cai Xueli, Ph.D

CONTACT

86-13967059836; xueli＿cai＿official@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 1\. Randomization results are known only to the patients themselves and the treating physicians. Baseline and in-hospital visits related to the study endpoint should be evaluated by a third party who is unknown to the patients' grouping and actual treatment status.2. Visits to the primary endpoint were conducted by trained third-party personnel. Standardized visits were conducted under the premise of unknown patient randomization and actual treatment status, and follow-up reports were prepared.3. All research-related image data will be collected for centralized interpretation. The images at each site were interpreted independently, and the readers were not aware of the patient's baseline condition, treatment received (except the images during baseline surgical treatment), and prognosis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: Carotid artery stenting after intracranial or middle cerebral artery embolization and balloon dilation of the extracranial segment of the ipsilateral internal carotid artery

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 13, 2023
• Study Start: June 14, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)