Preventing recurrent stroke with drug-eluting stents and aggressive medical treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of drug-eluting stent (DES) implantation combined with aggressive medical treatment compared to standard medical treatment alone in preventing recurrent strokes in patients with symptomatic intracranial atherosclerotic disease. It is a prospective, multi-center, randomized trial that aims to determine if this combined approach reduces the incidence of strokes or death within one year. The primary endpoints include any stroke or death within 30 days of enrollment or after a revascularization procedure, as well as ischemic strokes occurring in the territory of the qualifying artery beyond 30 days. Participants will be closely monitored for outcomes related to their treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age from 18 to 85 years
2. Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \[C5-C7\], middle cerebral artery \[M1\], vertebral artery \[V4\], or basilar artery) on CTA (According to WASID method)
3. The diameter of the target vessel between 2.0mm - 4.5mm
4. The stenosis lesion length ≤ 14 mm
5. Baseline modified Rankin Scale (mRS) score ≤ 3
6. Patient understands the purpose and requirements of the study, and has provided informed consent

Exclusion Criteria:

1. Ischemic stroke occurred within 7 days before enrolment
2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
5. Stroke caused by perforating artery occlusion
6. CT angiographic evidence of severe calcification at target lesion
7. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
8. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
9. History of stenting of an intracranial artery
10. Presence of any unequivocal cardiac source of embolism
11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
12. Cannot tolerate dual antiplatelet therapy
13. Contraindications to heparin, rapamycin, contrast and local or general anesthesia
14. Hemoglobin\<100g/L, platelet count \<100×109/L
15. Severe hepatic and renal dysfunction
16. INR\>1.5 or there are uncorrectable factors leading to bleeding
17. Major surgery within the past 30 days or planned within 90 days
18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
19. Life expectancy \<1 year
20. Pregnant or lactating women
21. Cannot complete the follow-up due to cognitive, emotional or mental illness
22. Other situations that are not suitable for enrolment according to the judgement of the investigator
23. Enrolment in another study that would conflict with the current study

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Daxing District People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Hejian People's Hospital
  Cangzhou, Hebei, China Recruiting
• North China University of Science and Technology Affiliated Hospital
  Tangshan, Hebei, China Recruiting
• Xingtai City Third Hospital
  Xingtai, Hebei, China Recruiting
• General Hospital of The Yangtze River Shipping
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Yongjun Wang, MD — Beijing Tiantan Hospital
• Study coordinator: Ning Ma, MD
• Email: maning_03@hotmail.com
• Phone: 13581889908

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.