🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04995159
Starting soon Not applicable

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

NCT04995159 · tracked via the Priya Life Science China tracker
Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
Phase
Not applicable
Started
2021-09
Last updated
2021-08-06

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

Single anti-platelet therapyDual anti-platelet therapy

Single anti-platelet therapy: Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.

Dual anti-platelet therapy: Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. * The stent with diameter more than 3.0mm is allowed to overlap with another stent once, the overlapping methods could be edge to edge or at most 1mm overlap. The total number of stents per patient is no more than 4, with a maximum of 2 stents per vessel (the 2.75mm diameter stent is not allowed to overlap). * Patient with indications for coronary artery bypass surgery. * Aspirin and clopidogrel could be used continuously during the study. * Patient who can understand the purpose of this trial, is willing to participate in the trial and to conduct clinical follow-up as required by the study protocol. Exclusion Criteria: * 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. * Severe heart failure (NYHA≥III or left ventricular ejection fraction\<35%). * Severe renal insufficiency, eGFR\<30ml/min/1.73m2 or serum creatinine\>2.5mg/dL (221μmol/L). * Patients with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half a year, fundus hemorrhage affecting vision, antiplatelet agents and anticoagulant treatment contraindications who cannot receive antithrombotic therapy. * Patients requiring long-term oral anticoagulants during the study period. * Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period. * Patients with malignancies, organ transplants, or drug addiction that can seriously affect study compliance. * Patients with contraindications to aspirin, clopidogrel or ticagrelor. * Known allergy to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, polylactic acid polymer and rapamycin. * Thrombosis occurred during previous clopidogrel treatment. * Life expectancy is less than 36 months. * Participated in clinical trials of other drugs or medical devices before enrollment and failed to meet the time limit of the primary end point. * Patients who will have elective surgery within a year and need to discontinue aspirin, clopidogrel or ticagrelor. * Subjects are deemed unsuitable for enrollment by investigators.

Primary outcome measure(s)

Trial sites (114)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
The First Affiliated Hospital with Anhui Medical University Hefei Anhui
The First Affiliated Hospital of Wannan Medical College Wuhu Anhui
Peking Union Medical College Hospital Beijing Beijing Municipality
Beijing Chaoyang Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Anzhen Hospital, Capital Medical University-12 Ward Beijing Beijing Municipality
Beijing Anzhen Hospital, Capital Medical University-28 Ward Beijing Beijing Municipality
Beijing Anzhen Hospital, Capital Medical University-33 Ward Beijing Beijing Municipality
Beijing Shijitan Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Xuan Wu Hospital, Capital Medical University Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Beijing Luhe Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Jingmei Group General Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Gansu Provincial Hospital Lanzhou Gansu
The First Hospital of Lanzhou University Lanzhou Gansu
Lanzhou University Second Hospital Lanzhou Gansu
Foshan First People's Hospital Foshan Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou Guangdong
The Third Affiliated Hospital of Guangdong Medical University Guangzhou Guangdong
Shantou Central Hospital Shantou Guangdong
The First Affiliated Hospital of Shantou University Medical College Shantou Guangdong
The Second Affiliated Hospital of Shantou University Medical College Shantou Guangdong
Shenzhen University General Hospital Shenzhen Guangdong
Zhanjiang Central People's Hospital Zhanjiang Guangdong
The Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong
Guilin People's Hospital Guilin Guangxi
Liuzhou People's Hospital Liuzhou Guangxi
Liuzhou Worker's Hospital Liuzhou Guangxi
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
The First People's Hospital of Nanning Nanning Guangxi
Yulin First People's Hospital Yulin Guangxi
Guizhou Provincial People's Hospital Guiyang Guizhou
Haikou People's Hospital Haikou Hainan
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan
Sanya Central Hospital (Hainan Third People's Hospital) Sanya Hainan
Cangzhou Central Hospital Cangzhou Hebei
Hengshui People's Hospital Hengshui Hebei

+ 74 more sites — see the full list on the official registry below.

More Lepu Medical Technology (Beijing) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04995159 on ClinicalTrials.gov ↗ ← All trials in China