Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion (NCT05902000) | Clinical Trial Compass
UnknownNot Applicable
Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion
China222 participantsStarted 2023-06-14
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Extracranial segment stenosis ≥70% or occlusion in tandem lesions.
Exclusion criteria
.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).
. 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;