Comparison Three Vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation

Launched by SINO MEDICAL SCIENCES TECHNOLOGY INC. · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two different lengths of treatment with a medication called Dual Anti-Platelet Therapy (DAPT) for patients who have received a special type of stent (a small tube to keep blood vessels open) in their brain. The trial aims to find out if taking DAPT for just 3 months is as safe and effective as taking it for 6 months after getting the stent. Participants will be randomly assigned to one of the two treatment groups, and the study is currently looking for patients aged 35 to 80 who have certain types of narrowing in their brain arteries.

If you decide to participate, you will receive either the short-term or long-term treatment and will be closely monitored throughout the trial. It’s important to note that there are certain health conditions that might prevent someone from joining, such as recent major surgery or specific types of strokes. The goal of this research is to help doctors understand the best duration for DAPT after stenting, which could lead to improved care for patients with similar conditions. If you're interested or think you might qualify, be sure to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Males or females between 35 and 80 years of age.
• • 2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
• • 3. Intracranial artery stenosis (≥70%) conformed by DSA.
• • 4. Subjects who voluntarily participate in the study and sign informed consent form.
• Exclusion Criteria:
• • 1. Subjects who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above).
• • 2. Subjects of acute hemorrhagic stroke within 3 months.
• • 3. Disabling stroke with a baseline mRS score ≥3.
• • 4. Lesion artery with severe calcification and close neighbour stenosis.
• • 5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm).
• • 6. The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as atrial fibrillation, mitral stenosis, left ventricular thrombus, patent foramen ovale, myocardial infarction within 6 weeks, etc.
• • 7. More than 50% stenosis of the supplying artery of the lesion artery: 1) MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery). 2) Basilar artery severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis.
• • 8. Accompanied by intracranial tumours or intracranial arteriovenous malformations.
• • 9. The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
• • 10. Women who are pregnant or lactating.
• • 11. Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
• • 12. Investigators consider the patient who is not suitable for enrolling in the present trial.