Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

⁃ Imaging Inclusion Criteria:

• 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.

Locations
Other Locations
China
Lishui Municipal Hospital
RECRUITING
Lishui
Contact Information
Primary
Li X Cai Xueli, Ph.D
xueli_cai_official@126.com
86-13967059836
Time Frame
Start Date: 2023-06-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 222
Treatments
Experimental: Thrombectomy + Carotid Stenting
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.
No_intervention: Thrombectomy alone
Intracranial thrombectomy alone(balloon dilation of the ipsilateral internal carotid artery if necessary)
Related Therapeutic Areas
Sponsors
Leads: Xueli Cai

This content was sourced from clinicaltrials.gov