Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Medical Technology (Beijing) Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 or above, male or non-pregnant female.

Evidence of myocardial ischemia (e.g., stable angina, unstable angina, medium-low risk NSTEMI, STEMI with onset more than 1 week, old myocardial infarction or asymptomatic myocardial ischemia), and suitable for PCI surgery.

The target lesion is in-situ coronary artery lesion, the total length of single lesion is no more than 40mm (the total length of stent is no more than 48mm), and the diameter of the target lesion is between 2.75mm and 3.75mm (visual measurement).

The diameter stenosis of target lesion is ≥70% in visual (or ≥50% with clinical evidence of myocardial ischemia in that range), and the TIMI blood flow is greater than grade 1.

Disqualifiers

Acute ST-segment elevation myocardial infarction within 1 week.

Left main coronary artery disease, branch vessel diameter≥2.0mm, three-vessel coronary artery disease and bridge vessel disease; visible thrombus in the target vessel.

Severe distortion, severe calcification that cannot be successfully predilated, and other lesions that are not suitable for stent delivery and deployment.

Intra-stent restenosis.

Trial design

Treatments tested in this trial

  • Single anti-platelet therapy
  • Dual anti-platelet therapy

Treatment groups

2,150 Participants
are divided into 2 treatment groups