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Coronary Heart DiseaseNCT04995159

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

A study testing Single anti-platelet therapy and Dual anti-platelet therapy in people with Coronary Heart Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 114 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Single anti-platelet therapy and Dual anti-platelet therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,150 participants
Where
114 sitesChina
Study dates
Sep 2021to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.

Trial locations and contacts

114 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ting Zhang contact

+86-010-80120666

ting_zhang@lepumedical.com

114 sites in 1 country

China114 sites

  • Baoji Central Hospital

    Baoji, Shanxi, 721008

    Yuhu Chun

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science

    Baotou, Inner Mongolia, 014017

    Hanjun Pei

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100005

    Zhicheng Jing

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

    Lefeng Wang

  • Beijing Anzhen Hospital, Capital Medical University-12 Ward

    Beijing, Beijing Municipality, 100029

    Yujie Zhou

  • Beijing Anzhen Hospital, Capital Medical University-28 Ward

    Beijing, Beijing Municipality, 100029

    Jinghua Liu

  • Beijing Anzhen Hospital, Capital Medical University-33 Ward

    Beijing, Beijing Municipality, 100029

    Xiantao Song

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100038

    Jianjun Peng

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Hongwei Li

  • Xuan Wu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Hengjian Hao

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Yida Tang

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101199

    Jincheng Guo

  • Beijing Jingmei Group General Hospital

    Beijing, Beijing Municipality, 102399

    Yu Wang

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

    Hongju Wang

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061011

    Jun Zhang

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Yuquan He

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

    Bin Liu

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130061

    Qian Tong

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

    Zaixin Yu

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

    Kanghua Ma

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

    Yuehui Yin

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

    Zhenguo Zheng

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning, 116089

    Xiaoqun Zheng

  • Foshan First People's Hospital

    Foshan, Guangdong, 528000

    Xili Yang

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi, 341000

    Yongling Liao

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510000

    Qiuxiong Chen

  • The Third Affiliated Hospital of Guangdong Medical University

    Guangzhou, Guangdong, 510150

    Ximing Chen

  • Guilin People's Hospital

    Guilin, Guangxi, 541002

    Yubin Wu

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550000

    Qiang Wu

  • Haikou People's Hospital

    Haikou, Hainan, 570208

    Bo Xing

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570216

    Yuewu Chen

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310016

    Guosheng Fu

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311100

    Hong Yuan

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Wei Yang

  • The Second Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Bo Yu

  • The First Affiliated Hospital with Anhui Medical University

    Hefei, Anhui, 230022

    Xianhe Lin

  • Hengshui People's Hospital

    Hengshui, Hebei, 053099

    Qun Zheng

  • Gynecology of Huai'an First People's Hospital, Nanjing Medical University

    Huai'an, Jiangsu, 223300

    Xiwen Zhang

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Jifu Li

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434020

    Keping Yang

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan, 650000

    Xiangbin Pan

  • The First People's Hospital of Yunnan

    Kunming, Yunnan, 650034

    Hong Zhang

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

    Ping Xie

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Ming Bai

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730099

    Xin Lin

  • Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine

    Lianyungang, Jiangsu, 222000

    Xin Wang

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

    Fangyong Jiang

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545006

    Hong Wang

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

    Lang Hong

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Xiaoping Peng

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Yanqing Wu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

    Genshan Ma

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Xiangqing Kong

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Lang Li

  • The First People's Hospital of Nanning

    Nanning, Guangxi, 530022

    Xianming Zhao

  • Nanyang Central Hospital

    Nanyang, Henan, 473005

    Gang Li

  • Nanyang Second General Hospital

    Nanyang, Henan, 473009

    Quanbao Shi

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Shanglang Cai

  • Sanya Central Hospital (Hainan Third People's Hospital)

    Sanya, Hainan, 571199

    Xiangqun Zhou

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

    Chun Liang

  • Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200025

    Ruiyan Zhang

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Ben He

  • Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200092

    Li Zhang

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Qi Zhang

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Xianxian Zhao

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200940

    Wenyi Yang

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality, 201306

    Chengxing Shen

  • Shantou Central Hospital

    Shantou, Guangdong, 515041

    Zhixiong Cai

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

    Bin Wang

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

    Jilin Li

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110016

    Zhanquan Li

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110066

    Yaling Han

  • Shenzhen University General Hospital

    Shenzhen, Guangdong, 518055

    Haiying Li

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050057

    Xiaoyong Qi

  • the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force

    Shijiazhuang, Hebei, 050082

    Leisheng Ru

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Bin Yang

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

    Jian An

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

    Hongliang Cong

  • Teda International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457

    Wenhua Lin

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

    Yining Yang

  • Weihai Central Hospital

    Weihai, Shandong, 264400

    Jianhua Zhou

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Xiang Cheng

  • Fifth Hospital in Wuhan

    Wuhan, Hubei, 430050

    Lifeng Hong

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Hong Jiang

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Xiaorong Hu

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

    Shengxing Tang

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Jie Deng

  • First Affiliated Hospital of the Fourth Military Medical University

    Xi’an, Shanxi, 710032

    Ling Tao

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Dongqi Wang

  • Shanxi Provincial Hospital

    Xi’an, Shanxi, 710068

    Xiling Shou

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 411199

    Mingxing Wu

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001

    Qingmin Wei

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453099

    Zhifang Wang

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453199

    Guo'an Zhao

  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu, 221005

    Yaojun Zhang

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

    Chunmei Qi

  • Tangdu Hospital of the Fourth Military Medical University of the PLA

    Yanan, Shanxi, 716000

    Yan Li

  • Yan'an University Affiliated Hospital

    Yanan, Shanxi, 716000

    Feng Gao

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

    Lin Zhong

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

    Shaobin Jia

  • Yingtan People's Hospital

    Yingtan, Jiangxi, 335000

    Jinying Tong

  • Yulin First People's Hospital

    Yulin, Guangxi, 537099

    Ping Li

  • Zhanjiang Central People's Hospital

    Zhanjiang, Guangdong, 524000

    Jie Chen

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450001

    Zhichen Zhao

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

    Lixia Wang

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450008

    Fengling Wang

  • The Second Affiliated Hospital, Zhengzhou University

    Zhengzhou, Henan, 450014

    Daguo Wan

  • The 7th People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450016

    Yujie Zhao

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan, 450052

    Xuming Yang

  • The First Affiliated Hospital, Zhengzhou University

    Zhengzhou, Henan, 450052

    Jinying Zhang

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou, Henan, 450099

    Yushan Chen

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 451460

    Chuanyu Gao

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Jian Chen

  • Zibo Central Hospital

    Zibo, Shandong, 255020

    Jun Wang

Other trials in China

About this study

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.

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.

Read the 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.

Being tested
Single anti-platelet therapy, Dual anti-platelet therapy
Keywords
Bioabsorbable Coronary Artery Rapamycin-eluting Stent System, Optimized Antiplatelet Therapy, Coronary Heart Disease, Randomized Controlled Trial
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single anti-platelet therapyDrug

    Also called SAPT strategy

    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 therapyDrug

    Also called DAPT strategy

    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 groups in NCT04995159
Study groupRoleWhat they receive
Poststent SAPT treatment cohortExperimentalreceiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with SAPT strategy
Receives: Drug: Single anti-platelet therapy
Poststent DAPT treatment cohortActive comparatorreceiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with DAPT strategy
Receives: Drug: Dual anti-platelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (11)

  1. Target lesion failure (TLF)

    Target lesion failure (TLF) includes cardiac death, target vessel myocardial infarction (TV-MI) and ischemic-driven target lesion revascularization (ID-TLR).

    Measured: 3 years

  2. Comparison of net adverse clinical events

    Measured: 30 days, 6 months, 1 year, 2 years, 4 years, and 5 years

  3. Bleeding events of grade 3 and 5 as defined by BARC

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  4. Bleeding events of grade 2, 3 and 5 as defined by BARC

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  5. Bleeding events of grade 1, 2, 3 and 5 as defined by BARC

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  6. Comparison of target lesion failures

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  7. Patient-oriented composite endpoint (PoCE)

    Patient-oriented composite endpoint (PoCE) includes all-cause death, all MI, any revascularization, and stroke.

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  8. Ischemic-driven target lesion revascularization (iTLR)

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  9. Ischemic-driven target vessel revascularization (iTVR)

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  10. All cardiac revascularization

    All cardiac revascularization includes PCI and CABG.

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  11. Two types of stent thrombosis events as defined by BRS_ARC2

    Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995159
Sponsor's protocol ID
OPT-BRS
Status last verified
Jul 2021
First submitted
29 Jul 2021
Last updated
6 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Single anti-platelet therapy and Dual anti-platelet therapy in people with Coronary Heart Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 114 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ting Zhang (+86-010-80120666, ting_zhang@lepumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net adverse clinical event (NACE) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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