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Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion

NCT05902000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2023-06-28

No results posted yet for this study

Summary

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. 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

Interventions

DEVICE

Carotid Stenting

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.

PROCEDURE

Thrombectomy

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

DRUG

Dual antiplatelet treatment

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.

DRUG

Intraoperative Drug Treatment

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.

Sponsors & Collaborators

  • Xueli Cai

    lead OTHER_GOV

Principal Investigators

  • Li X Cai · Lishui Municipal Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05902000 on ClinicalTrials.gov