Trials / Withdrawn
WithdrawnNCT06857045
Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation
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
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sino Medical Sciences Technology Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-07-09
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-03-04
- Last updated
- 2025-11-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06857045. Inclusion in this directory is not an endorsement.