Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
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.
1 other identifier
interventional
2,150
1 country
114
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedAugust 6, 2021
July 1, 2021
4.3 years
July 29, 2021
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net adverse clinical event (NACE)
NACE includes POCE (including all-cause death, all non-fatal myocardial infarction (Universal Definition of Myocardial Infarction, 4th Edition), any revascularization, and stroke), and major bleeding events of grade 2, 3, and 5 as defined by BARC.
3 years
Secondary Outcomes (11)
Target lesion failure (TLF)
3 years
Comparison of net adverse clinical events
30 days, 6 months, 1 year, 2 years, 4 years, and 5 years
Bleeding events of grade 3 and 5 as defined by BARC
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Bleeding events of grade 2, 3 and 5 as defined by BARC
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Bleeding events of grade 1, 2, 3 and 5 as defined by BARC
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
- +6 more secondary outcomes
Study Arms (2)
Poststent SAPT treatment cohort
EXPERIMENTALreceiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with SAPT strategy
Poststent DAPT treatment cohort
ACTIVE COMPARATORreceiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with DAPT strategy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233099, China
The First Affiliated Hospital with Anhui Medical University
Hefei, Anhui, 230022, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Beijing Anzhen Hospital, Capital Medical University-12 Ward
Beijing, Beijing Municipality, 100029, China
Beijing Anzhen Hospital, Capital Medical University-28 Ward
Beijing, Beijing Municipality, 100029, China
Beijing Anzhen Hospital, Capital Medical University-33 Ward
Beijing, Beijing Municipality, 100029, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Xuan Wu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101199, China
Beijing Jingmei Group General Hospital
Beijing, Beijing Municipality, 102399, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730099, China
Foshan First People's Hospital
Foshan, Guangdong, 528000, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000, China
The Third Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, 510150, China
Shantou Central Hospital
Shantou, Guangdong, 515041, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Shenzhen University General Hospital
Shenzhen, Guangdong, 518055, China
Zhanjiang Central People's Hospital
Zhanjiang, Guangdong, 524000, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
Guilin People's Hospital
Guilin, Guangxi, 541002, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545006, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The First People's Hospital of Nanning
Nanning, Guangxi, 530022, China
Yulin First People's Hospital
Yulin, Guangxi, 537099, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
Haikou People's Hospital
Haikou, Hainan, 570208, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570216, China
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, Hainan, 571199, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061011, China
Hengshui People's Hospital
Hengshui, Hebei, 053099, China
Hebei General Hospital
Shijiazhuang, Hebei, 050057, China
the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
Shijiazhuang, Hebei, 050082, China
Xingtai People's Hospital
Xingtai, Hebei, 054001, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The Second Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Nanyang Central Hospital
Nanyang, Henan, 473005, China
Nanyang Second General Hospital
Nanyang, Henan, 473009, China
Xinxiang Central Hospital
Xinxiang, Henan, 453099, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450001, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450008, China
The Second Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, 450014, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, 450016, China
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, Henan, 450052, China
The First Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, 450052, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450099, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451460, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Fifth Hospital in Wuhan
Wuhan, Hubei, 430050, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
Xiangtan Central Hospital
Xiangtan, Hunan, 411199, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science
Baotou, Inner Mongolia, 014017, China
Gynecology of Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300, China
Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine
Lianyungang, Jiangsu, 222000, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, 221005, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 341000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Yingtan People's Hospital
Yingtan, Jiangxi, 335000, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130061, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116089, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110066, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Weihai Central Hospital
Weihai, Shandong, 264400, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Zibo Central Hospital
Zibo, Shandong, 255020, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200092, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200940, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 201306, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
First Affiliated Hospital of the Fourth Military Medical University
Xi’an, Shanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shanxi Provincial Hospital
Xi’an, Shanxi, 710068, China
Tangdu Hospital of the Fourth Military Medical University of the PLA
Yanan, Shanxi, 716000, China
Yan'an University Affiliated Hospital
Yanan, Shanxi, 716000, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650000, China
The First People's Hospital of Yunnan
Kunming, Yunnan, 650034, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yaling Han
The General Hospital of Northern Theater Command
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 6, 2021
Study Start
September 1, 2021
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
August 6, 2021
Record last verified: 2021-07