Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-03-05 @ 8:40 AM
Study NCT ID:
NCT04995159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-06
First Post:
2021-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Organization:
Study Overview
Official Title:
Evaluate the Safety and Efficacy of Optimized Antiplatelet Therapy in Patients With Coronary Heart Disease After Implantation of NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to verify the safety and efficacy of Lepu® NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System combined with different antiplatelet therapies in the treatment of coronary heart disease.
Detailed Description:
A total of 2150 subjects are planned to be enrolled in this trial. Subjects meeting the inclusion criteria and without exclusion criteria are implanted with NeoVas™ stents and randomly assigned to the experimental group and the control group in a 1:1 ratio. Patients in both groups will receive aspirin in combination with a P2Y12 receptor antagonist in the first year after PCI (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia). Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery in the experimental group. The control group will continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.
Subjects will be followed up at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery to observe whether the net adverse clinical events (NACEs) and other end points occur or not.
Subjects will be followed up at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery to observe whether the net adverse clinical events (NACEs) and other end points occur or not.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: