Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implan… (NCT06857045) | Clinical Trial Compass
WithdrawnNot Applicable
Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation
Stopped: Subgroup analysis based on the main study (NCT05692882), not registered separately.
China0Started 2024-07-09
Plain-language summary
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 months of DAPT at index procedure.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Males or females between 35 and 80 years of age.
✓. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
✓. Intracranial artery stenosis (≥70%) conformed by DSA.
✓. Subjects who voluntarily participate in the study and sign informed consent form.
Exclusion criteria
✕. Subjects who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above).
✕. Subjects of acute hemorrhagic stroke within 3 months.
✕. Disabling stroke with a baseline mRS score ≥3.
✕. Lesion artery with severe calcification and close neighbour stenosis.
✕. 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).
✕. 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.
✕. 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.
✕. Accompanied by intracranial tumours or intracranial arteriovenous malformations.