Clinical trial NCT06857045: Comparison Three Vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation
Official title: A Prospective, Multicenter, Open-label, Randomized Controlled Trial of 3-month Versus 6-month Dual Antiplatelet Therapy After Implantation of NOVA Intracranial Sirolimus-eluting Stent System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Arteriosclerosis
Intracranial Artery Stenosis
Drug-Eluting Stents
Keywords: intracranial drug-eluting stent
symptomatic intracranial artery stenosis (sICAS)
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will recruit 478 subjects with intracranial atherosclerotic stenosis (ICAS) in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 6 months of DAPT after implanting NOVA stent. Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 1 year, 2 years, 3 years, 4 years and 5 years after index procedure. The primary endpoint is the composite endpoint of any stroke, death and major bleeding (intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery) at 1 year.

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.

Primary outcomes:
measure: Any stroke, death and major bleeding
timeFrame: 1 year after operation
Secondary outcomes:
measure: Any stroke or death within 30 days or any ischemic stroke from the original culprit intracranial artery beyond 30 days through 12 months after operation.
timeFrame: 1 year after operation
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
timeFrame: 30 days after operation
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation
timeFrame: 30 days after operation
measure: Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)
timeFrame: 1, 2, 3, 4 years and 5 years after operation
measure: Rate of Device defect
timeFrame: within 5 years of whole trial
measure: Rate of bleeding events at 1 years after operation
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of China Medical University
Study officials:
affiliation: The Fourth Affiliated Hospital of China Medical University
name: Lianbo Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jianfeng Han
role: PRINCIPAL_INVESTIGATOR
References: