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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Single anti-platelet therapy; Drug: Dual anti-platelet therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Zhang; Phone Number: +86-010-80120666; Email: ting_zhang@lepumedical.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233099
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Hongju Wang
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital with Anhui Medical University
      • Contact: xianhe lin
    • Wuhu, Anhui, China, 241001
      • The first affiliated hospital of Wannan Medical College
      • Contact: Shengxing Tang
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Yida Tang
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Hongwei Li
    • Beijing, Beijing, China, 100005
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital, Capital Medical University
      • Contact: Jianjun Peng
    • Beijing, Beijing, China, 100020
      • Beijing Chaoyang Hospital, Capital Medical University
      • Contact: Lefeng Wang
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University-12 Ward
      • Contact: Yujie Zhou
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University-28 Ward
      • Contact: Jinghua Liu
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University-33 Ward
      • Contact: Xiantao Song
    • Beijing, Beijing, China, 100053
      • Xuan Wu Hospital, Capital Medical University
      • Contact: Hengjian Hao
    • Beijing, Beijing, China, 101199
      • Beijing Luhe Hospital, Capital Medical University
      • Contact: Jincheng Guo
    • Beijing, Beijing, China, 102399
      • Beijing Jingmei Group General Hospital
      • Contact: Yu Wang
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Kanghua Ma
    • Chongqing, Chongqing, China, 400042
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Yuehui Yin
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
      • Contact: Ming Bai
    • Lanzhou, Gansu, China, 730000
      • Gansu Provincial Hospital
      • Contact: Ping Xie
    • Lanzhou, Gansu, China, 730099
      • Lanzhou University Second Hospital
      • Contact: Xin Lin
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Foshan First People's Hospital
      • Contact: Xili Yang
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Contact: Qiuxiong Chen
    • Guangzhou, Guangdong, China, 510150
      • The Third Affiliated Hospital of Guangdong Medical University
      • Contact: Ximing Chen
    • Shantou, Guangdong, China, 515041
      • The First Affiliated Hospital of Shantou University Medical College
      • Contact: Bin Wang
    • Shantou, Guangdong, China, 515041
      • Shantou Central Hospital
      • Contact: Zhixiong Cai
    • Shantou, Guangdong, China, 515041
      • The Second Affiliated Hospital of Shantou University Medical College
      • Contact: Jilin Li
    • Shenzhen, Guangdong, China, 518055
      • Shenzhen university General Hospital
      • Contact: Haiying Li
    • Zhanjiang, Guangdong, China, 524000
      • Zhanjiang Central People's Hospital
      • Contact: Jie Chen
    • Zhuhai, Guangdong, China, 519000
      • The Fifth Affiliated Hospital of Sun Yat-sen University
  • Guangxi
    • Guilin, Guangxi, China, 541002
      • Guilin People's Hospital
      • Contact: Yubin Wu
    • Liuzhou, Guangxi, China, 545006
      • Liuzhou People's Hospital
      • Contact: Fangyong Jiang
    • Liuzhou, Guangxi, China, 545006
      • Liuzhou Worker's Hospital
      • Contact: Hong Wang
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Lang Li
    • Nanning, Guangxi, China, 530022
      • The First People's Hospital of Nanning
      • Contact: Xianming Zhao
    • Yulin, Guangxi, China, 537099
      • Yulin First People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Guizhou Provincial People's Hospital
      • Contact: Qiang Wu
  • Hainan
    • Haikou, Hainan, China, 570208
      • Haikou People's Hospital
      • Contact: Bo Xing
    • Haikou, Hainan, China, 570216
      • The Second Affiliated Hospital of Hainan Medical University
      • Contact: Yuewu Chen
    • Sanya, Hainan, China, 571199
      • Sanya Central Hospital (Hainan Third People's Hospital)
      • Contact: Xiangqun Zhou
  • Hebei
    • Cangzhou, Hebei, China, 061011
      • Cangzhou Central Hospital
      • Contact: Jun Zhang
    • Hengshui, Hebei, China, 053099
      • Hengshui People's Hospital
      • Contact: Qun Zheng
    • Shijiazhuang, Hebei, China, 050082
      • the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
      • Contact: Leisheng Ru
    • Shijiazhuang, Hebei, China, 050057
      • Hebei General Hospital
      • Contact: Xiaoyong Qi
    • Xingtai, Hebei, China, 054001
      • Xingtai People's Hospital
      • Contact: Qingmin Wei
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150086
      • The Second Hospital of Harbin Medical University
      • Contact: bo Yu
  • Henan
    • Nanyang, Henan, China, 473005
      • Nanyang Central Hospital
      • Contact: Gang Li
    • Nanyang, Henan, China, 473009
      • Nanyang second general hospital
      • Contact: Quanbao Shi
    • Xinxiang, Henan, China, 453099
      • Xinxiang Central Hospital
      • Contact: Zhifang Wang
    • Xinxiang, Henan, China, 453199
      • The First Affiliated Hospital of Xinxiang Medical University
      • Contact: Guo'an Zhao
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
      • Contact: Lixia Wang
    • Zhengzhou, Henan, China, 450016
      • The 7th People's Hospital of Zhengzhou
      • Contact: Yujie Zhao
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital, Zhengzhou University
      • Contact: Jinying Zhang
    • Zhengzhou, Henan, China, 450001
      • Zhengzhou Central Hospital
      • Contact: Zhichen Zhao
    • Zhengzhou, Henan, China, 450008
      • Henan Provincial Chest Hospital
      • Contact: Fengling Wang
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital, Zhengzhou University
      • Contact: Daguo Wan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Xuming Yang
    • Zhengzhou, Henan, China, 450099
      • The First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Yushan Chen
    • Zhengzhou, Henan, China, 451460
      • Fuwai Central China Cardiovascular Hospital
      • Contact: Chuanyu Gao
  • Hubei
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
      • Contact: Keping Yang
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
      • Contact: Xiaorong Hu
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
      • Contact: Hong Jiang
    • Wuhan, Hubei, China, 430050
      • Fifth Hospital in Wuhan
      • Contact: Lifeng Hong
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: xiang Cheng
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University
    • Xiangtan, Hunan, China, 411199
      • Xiangtan Central Hospital
      • Contact: Mingxing Wu
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014017
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science
      • Contact: Hanjun Pei
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Gynecology of Huai'an First People's Hospital, Nanjing Medical University
      • Contact: Xiwen Zhang
    • Lianyungang, Jiangsu, China, 222000
      • Affiliated Lianyungang Hospital of Nanjing University of Chinese Medicine
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Xiangqing Kong
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
      • Contact: Genshan Ma
    • Xuzhou, Jiangsu, China, 221006
      • The Affiliated Hospital Of XuZhou Medical University
      • Contact: Chunmei Qi
    • Xuzhou, Jiangsu, China, 221005
      • Xuzhou cancer hospital
      • Contact: Yaojun Zhang
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • The First Affiliated Hospital of Gannan Medical College
      • Contact: Yongling Liao
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital Of Nanchang University
      • Contact: xiaoping Peng
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Yanqing Wu
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
      • Contact: Lang Hong
    • Yingtan, Jiangxi, China, 335000
      • Yingtan People's Hospital
      • Contact: Jinying Tong
  • Jilin
    • Changchun, Jilin, China, 130033
      • China-Japan Union Hospital of Jilin University
      • Contact: Yuquan He
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
      • Contact: Bin Liu
    • Changchun, Jilin, China, 130061
      • The First Bethune Hospital of Jilin University
      • Contact: Qian Tong
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Affiliated Zhongshan Hospital of Dalian University
      • Contact: Zhenguo Zheng
    • Dalian, Liaoning, China, 116089
      • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
      • Contact: Xiaoqun Zheng
    • Shenyang, Liaoning, China, 110016
      • The People's Hospital of Liaoning Province
      • Contact: Zhanquan Li
    • Shenyang, Liaoning, China, 110066
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • General Hospital of Ningxia Medical University
      • Contact: Shaobin Jia
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital Of Shandong University
      • Contact: Jifu Li
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University
      • Contact: Shanglang Cai
    • Weihai, Shandong, China, 264400
      • Weihai Central Hospital
      • Contact: Jianhua Zhou
    • Yantai, Shandong, China, 264099
      • Yantai Yuhuangding Hospital
      • Contact: Lin Zhong
    • Zibo, Shandong, China, 255020
      • Zibo central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital
      • Contact: Xianxian Zhao
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital
      • Contact: Qi Zhang
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
      • Contact: Ben He
    • Shanghai, Shanghai, China, 200003
      • Shanghai Changzheng Hospital
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiaotong University
    • Shanghai, Shanghai, China, 200940
      • Shanghai General Hospital
      • Contact: Wenyi Yang
    • Shanghai, Shanghai, China, 201306
      • Shanghai 6th People's Hospital
      • Contact: Chengxing Shen
  • Shanxi
    • Baoji, Shanxi, China, 721008
      • Baoji Central Hospital
      • Contact: Yuhu Chun
    • Taiyuan, Shanxi, China, 030001
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030024
      • Shanxi Cardiovascular Hospital
      • Contact: Jian An
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'An JiaoTong University
      • Contact: Dongqi Wang
    • Xi'an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Jie Deng
    • Xi'an, Shanxi, China, 710032
      • First Affiliated Hospital of the Fourth Military Medical University
      • Contact: Ling Tao
    • Xi'an, Shanxi, China, 710068
      • Shanxi Provincial Hospital
      • Contact: Xiling Shou
    • Yanan, Shanxi, China, 716000
      • Tangdu Hospital of the Fourth Military Medical University of the PLA
    • Yanan, Shanxi, China, 716000
      • Yan'an University Affiliated Hospital
      • Contact: Feng Gao
  • Tianjin
    • Tianjin, Tianjin, China, 300457
      • TEDA International Cardiovascular Hospital
      • Contact: Wenhua Lin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Chest Hospital
      • Contact: Hongliang Cong
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region
      • Contact: Yining Yang
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Fuwai Yunnan Cardiovascular Hospital
      • Contact: Xiangbin Pan
    • Kunming, Yunnan, China, 650034
      • The First People's Hospital of Yunnan
      • Contact: hong Zhang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University
      • Contact: guosheng Fu
    • Hangzhou, Zhejiang, China, 311100
      • The second affiliated hospital of zhejiang university school of medicine
      • Contact: Hong Yuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Poststent SAPT treatment cohort; receiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with SAPT strategy	Drug: 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.; Other Names: SAPT strategy
Active Comparator: Poststent DAPT treatment cohort; receiving the treatment with NeoVas™ Bioabsorbable Coronary Artery Rapamycin-eluting Stent System of Lepu Medical combined with DAPT strategy	Drug: 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.; Other Names: DAPT strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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
Comparison of target lesion failures		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Patient-oriented composite endpoint (PoCE)	Patient-oriented composite endpoint (PoCE) includes all-cause death, all MI, any revascularization, and stroke.	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Ischemic-driven target lesion revascularization (iTLR)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Ischemic-driven target vessel revascularization (iTVR)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
All cardiac revascularization	All cardiac revascularization includes PCI and CABG.	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Two types of stent thrombosis events as defined by BRS_ARC2		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Collaborators and Investigators

• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
• Investigators: Study Chair: Yaling Han, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Coronary Heart Disease; Bioabsorbable Coronary Artery Rapamycin-eluting Stent System; Optimized Antiplatelet Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: OPT-BRS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No