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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-09

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)

NCT02578069

Ischemic Stroke

COMPLETED NA

Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

NCT03287167

Coronary Disease Drug Eluting Stent Percutaneous Coronary Intervention +1 more

UNKNOWN PHASE4

Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation

NCT03008083

Drug-Eluting Stents Percutaneous Coronary Intervention

UNKNOWN PHASE4

Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

NCT00691314

Stroke Transient Ischemic Attack Atherosclerosis +2 more

COMPLETED NA

Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

NCT07197970

Symptomatic Intracranial Atherosclerotic Stenosis

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Arteriosclerosis Intracranial Artery Stenosis Drug-Eluting Stents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3 months DAPT Intervention

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.

Group Type EXPERIMENTAL

NOVA intracranial sirolimus-eluting stent system

Intervention Type DEVICE

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

6 months DAPT Intervention

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.

Group Type ACTIVE_COMPARATOR

NOVA intracranial sirolimus-eluting stent system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NOVA intracranial sirolimus-eluting stent system

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No