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

NCT06857045 | Withdrawn

• 1 other identifier: NOVA II-DAPT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Arteriosclerosis; Intracranial Artery Stenosis; Drug-Eluting Stents

Keywords

intracranial drug-eluting stent; symptomatic intracranial artery stenosis (sICAS)

Outcome Measures

Primary Outcomes (1)

• Any stroke, death and major bleeding

  Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery.

  1 year after operation

Secondary Outcomes (13)

• 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.

  1 year after operation

• Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation

  30 days after operation

• Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation

  30 days after operation

• Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

• 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

  3, 6 months, 1, 2, 3, 4 years and 5 years after operation

Study Arms (2)

3 months DAPT Intervention

EXPERIMENTAL

After implantation of NOVA stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 3 months.

Device: NOVA intracranial sirolimus-eluting stent system

6 months DAPT Intervention

ACTIVE COMPARATOR

After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 6 months.

Device: NOVA intracranial sirolimus-eluting stent system

Interventions

NOVA intracranial sirolimus-eluting stent system DEVICE

The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon.

3 months DAPT Intervention; 6 months DAPT Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
• Women who are pregnant or lactating.
• Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
• Investigators consider the patient who is not suitable for enrolling in the present trial.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead

Study Sites (1)

The Fourth Affiliated Hospital of China Medical University

Ha’erbin, China

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lianbo Gao

  The Fourth Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Jianfeng Han

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: July 9, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (1)