Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation
NCT06857045 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-11-25
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
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Sino Medical Sciences Technology Inc.
lead INDUSTRY
Principal Investigators
-
Lianbo Gao · The Fourth Affiliated Hospital of China Medical University
-
Jianfeng Han · First Affiliated Hospital Xi'an Jiaotong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-09
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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