Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS)

June 30, 2023 updated by: Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China

A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Clinical Study to Evaluate the Safety and Efficacy of Intracranial Balloon Angioplasty Plus Aggressive Medical Management for Symptomatic Intracranial Artery Stenosis

Intracranial atherosclerotic disease (ICAD) is the most common cause of ischemical cerebrovascular events. The risk of stroke recurrence or death of ICAD patients remains very high. Even with aggressive medical management including dual antiplatelet therapy and strict management of risk factors, 12.2 percent of patients with 70-99 percent stenosis of intracranial artery had stroke or death during 1 year follow-up. In the real world, the 30-day risk of recurrent stroke of patients with aggressive medical management was as high as 20.2 percent. Balloon angioplasty and stent for intracranial artery have become important alternative treatments to prevent recurrent stroke for patients with severe intracranial atherosclerotic stenosis. Nevertheless, the SAMMPRIS trial has suggested intracranial stenting has higher stroke and death rate than aggressive medication with high peri-procedure complication rate. Previous nonrandomized studies have showed that stroke and death rate of angioplasty for ICAD patients with severe stenosis of intracranial artery is lower than that of aggressive medication. The primary purpose of this trial is to compare intracranial angioplasty plus aggressive medical management with aggressive medical management alone for the treatment of patients with 70-99 percent intracranial artery stenosis because of ICAD and to clarify the efficacy and safety of intracranial angioplasty through a multicenter, prospective, randomized, open-label, blinded end-point trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is a multicenter, prospective, randomized, parallel controlled trial. A total of approximately 512 patients (35-80 years of age) with primary or recurrent sICAS (a recent TIA[<90 days] or ischemic stroke [14-90 days] before enrollment attributed to 70-99% atherosclerotic stenosis of a major intracranial artery) receiving treatment with at least one antithrombotic drug and/or standard medical management of vascular risk factors will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized into two groups according to the 1:1 ratio after offering informed content: 1) Experimental group will receive intracranial angioplasty plus aggressive medical management which is the same as the control group; 2) Control group will receive aggressive medical management only. Aggressive medical management includes 100 mg/day of aspirin during the follow-up period; 75 mg/day of clopidogrel within 90 days after enrollment, and whether clopidogrel should continue to be used depends on the actual situation of the subjects; 20-80mg/day of atorvastatin should be used during the year after enrollment, and dose adjustment to target LDL <1.8mmol/L or <70 mg/dl. Both groups will receive risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L. The primary objective is to evaluate the safety and efficacy of intracranial angioplasty combined with aggressive medical management for symptomatic intracranial artery stenosis. The study consists of 11 visits including the day of screening and randomization, the day when the subject receive intracranial angioplasty and/or aggressive medical management, the day before the subject is discharged from hospital, 30, 90,180 days and 1 year after enrollment, and every half a year after then until the third year. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The trial is anticipated to last from October 2018 to May 2025 with 512 subjects recruited from 31 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by the ethics committee of Beijing Tiantan Hospital and corresponding branch centers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
512

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xuan Sun, MD
  • Phone Number: +8613810926284
  • Email: sxuan@yeah.net

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230031
        • The First Affiliated Hospital of Anhui University of CM
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100070
        • Beijing Tian Tan Hospital, Capital Medical University
      • Beijing, Beijing, China, 100020
        • Beijing Chao-Yang Hospital, Capital Medical University
      • Beijing, Beijing, China, 100069
        • Beijing Fengtai You Anmen Hospital
      • Beijing, Beijing, China, 100078
        • Dongfang Hospital Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 101149
        • Beijing Luhe Hospital,Capital Medical University
      • Beijing, Beijing, China, 101300
        • Beijing Shunyi Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Guangzhou, Guangdong, China, 510260
        • The second Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital,Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510510
        • Guangdong Sanjiu Brain Hospital
      • Shenzhen, Guangdong, China, 518110
        • Shenzhen Hospital of Southern Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • The Affiliated Hospital of Guizhou Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan No.1 Hospital
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • The First People's Hospital of Changzhou
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Nanjing, Jiangsu, China, 210008
        • The Second Affiliated Hospital of Nanjing Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Jilin
      • Chang chun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110015
        • General Hospital of the Northern Theater of the Chinese People's Liberation Army
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Liaocheng, Shandong, China, 252000
        • LiaochengI People's Hospital
      • Qingdao, Shandong, China, 266000
        • The affiliated hospital of Qingdao university
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xian, Shanxi, China, 100005
        • The Affiliated Hospital of Northwest University
    • Sichuan
      • Chendu, Sichuan, China, 610041
        • West China Hospital Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 35-80 years.
  2. Participants with primary or recurrent sICAS (a recent TIA[<90 days] or ischemic stroke [14-90 days] before enrollment attributed to 70-99% atherosclerotic stenosis of a major intracranial artery) receiving treatment with at least one antithrombotic drug and/or standard medical management of vascular risk factors;
  3. Diagnosed by DSA: a major intracranial artery (terminal internal carotid artery [ICA] [C4-C7 segments], middle cerebral artery [MCA] M1 segment, vertebral artery [VA] V4 segment, and basilar artery [BA]) severe atherosclerotic stenosis (70-90% according to WASID method) with lesion length ≤ 10mm, diameter ≥1.5mm, and normal distal artery. (Regarding the curvature and angle of the lesion, whether the patient is enrolled in BASIS per the investigator's determination based on the patient's situation);
  4. Informed consent signed.

Exclusion Criteria:

  1. Surgery within the past 30 days or plan to receive ≥ 3-grade surgery within 90 days;
  2. Thrombolytic therapy within 24 hours before enrollment;
  3. Neurological deficits worsen within 24 hours before enrollment;
  4. Acute ischemic stroke onset within 14 days before enrollment;
  5. Other intracranial arteries with severe stenosis (70-99%) besides the target artery and its supplying artery;
  6. Target artery's supplying artery stenosis > 50%. For example, patient with MCA severe stenosis (target artery) and the ipsilateral ICA stenosis > 50% should be excluded; patient with BA severe stenosis (target artery) and the dominant VA stenosis > 50% should be excluded; the patient with extracranial artery (non-lesion side) stenosis > 70% should be excluded; For patients with balanced VA, if bilateral VA stenosis > 70% at the same time, should be excluded (unable to determine which VA is the lesion artery). However, if patient's dominant VA is the lesion artery with a dysplasia or slender contralateral VA or a non-dominant contralateral VA terminating at posteroinferior cerebellar artery, should not be excluded.
  7. Participant with perforator stroke (except for severe stenosis of supplying artery combined with hemodynamic compromise or poor collaterals) 12;
  8. Baseline modified Rankin Scale ≥ 3;
  9. Non-atherosclerotic diseases (e.g., arterial dissection, moyamoya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
  10. Target artery with severely calcified and adjacent to stenosis;
  11. Suspected ischemic event caused by embolism or the arterial embolism from extracranial segment (ipsilateral chest or neck vascular occlusive disease) or potential cardioembolism (e.g., atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
  12. Coexistent with Intracranial tumors, aneurysms or intracranial arteriovenous malformations;
  13. Intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage or subdural hemorrhage, etc.;
  14. Angioplasty procedure (including balloon dilatation, stenting, or endarterectomy) performed at the original target vessel or its primary supplying artery, or a planned stenting procedure;
  15. Unable to receive dual antiplatelet therapy due to other diseases;
  16. Tortuous vascular approach that cannot be stabilized to obtain vascular access;
  17. Allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components;
  18. Hemoglobin < 100g/L, platelet count < 100×109/ L, international normalized ratio (INR) >1.5 (irreversible), Coagulation dysfunction or uncorrectable bleeding factors;
  19. Severe liver or kidney dysfunction. ALT > three-fold higher than the upper limit of normal value or AST > three-fold higher than the upper limit of normal value, or serum creatinine > two-fold higher than the upper limit of normal value;
  20. Pregnant and lactating women;
  21. Participants with renal artery, radial artery, and cardiac coronary artery requiring concurrent intervention;
  22. Expected survival expectation is less than< 1 year;
  23. Unable to complete follow-up due to mental illness, cognitive or emotional disorders;
  24. Participants participating in other drug/medical device clinical trials who have not yet completed the program requirements;
  25. Participants are not suitable for BASIS trial per investigator's opinion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intracranial balloon angioplasty and aggressive medical management
All the participants in this group will be given Intracranial balloon angioplasty and aggressive medical management.
Device: intracranial balloon angioplasty
A balloon (recommending the Neuro RX and Neuro LPS Intracranial Balloon Dilation Catheter [Sinomed Inc., Tianjin, China]) is navigated by the microwire to the lesion of the target artery.
Drug: aggressive medical management
Aspirin 100mg once/day during the follow-up period, Clopidogrel 75mg once/day for at least 90 days, Atorvastatin 20-80mg once/day as the situation requires and risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L.
Experimental: Aggressive Medical management
All the participants in this group will be given aggressive medical management alone.
Drug: aggressive medical management
Aspirin 100mg once/day during the follow-up period, Clopidogrel 75mg once/day for at least 90 days, Atorvastatin 20-80mg once/day as the situation requires and risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroke or death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke or revascularization from the qualifying artery beyond 30 days through 12 months after enrollment
Time Frame: 12 months
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after enrollment.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Any stroke (ischemic or hemorrhage stroke) or all-cause deaths within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up
Time Frame: 30 days
Any stroke (ischemic or hemorrhage stroke) or all-cause deaths within 30 days after enrollment or after balloon. angioplasty procedure of the qualifying lesion during follow-up.
30 days
Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 90 days after enrollment
Time Frame: 90 days
Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 90 days after enrollment.
90 days
Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 90 days after enrollment
Time Frame: 90 days
Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 90 days after enrollment.
90 days
Neurological improvement assessed by mRS at 90 days
Time Frame: 90 days
Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.
90 days
Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 12 months after enrollment
Time Frame: 12 months
Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 12 months after enrollment.
12 months
Revascularization of the target artery within 12 months after enrollment
Time Frame: 12 months
Rat of revascularization of the target artery within 12 months after enrollment.
12 months
Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 12 months after enrollment
Time Frame: 12 months
Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 12 months after enrollment.
12 months
Neurological improvement assessed by mRS at 12 months
Time Frame: 12 months
Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.
12 months
Restenosis rate of the target artery within 12 months (defined as rate of stenosis >70% or increased by 30% based on following-up neurovascular imaging)
Time Frame: 12 months
Restenosis is defined as rate of stenosis >70% or increased by 30% based on following-up neurovascular imaging.
12 months
Combined events such as stroke, myocardial infarction, and vascular death within 12 months after enrollment
Time Frame: 12 months
Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.
12 months
Life quality assessment (EuroQol-5-Dimensions Scale [EQ-5D] questionnaire) within 12 months after enrollment
Time Frame: 12 months
Quality of life evaluated by EuroQol-5-Dimensions Scale (EQ-5D) questionnaire at the 12 months follow-up. EQ-5D descriptive system covers five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels (no problem, some problems, and severe problems). The EQ-5D descriptive system generates 243 health states, each of which was assigned a utility. score ranging from -0.59 to 1.00 (full health)
12 months
Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 24 months after enrollment
Time Frame: 24 months
Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 24 months after enrollment.
24 months
Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 24 months after enrollment
Time Frame: 24 months
Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 24 months after enrollment.
24 months
Neurological improvement assessed by mRS at 24 months
Time Frame: 24 months
Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.
24 months
Combined events such as stroke, myocardial infarction, and vascular death within 24 months after enrollment
Time Frame: 24 months
Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.
24 months
Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 36 months after enrollment
Time Frame: 36 months
Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 36 months after enrollment.
36 months
Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 36 months after enrollment
Time Frame: 36 months
Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery or all-cause deaths within 36 months after enrollment.
36 months
Neurological improvement assessed by mRS at 36 months
Time Frame: 36 months
Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.
36 months
Combined events such as stroke, myocardial infarction, and vascular death within 36 months after enrollment
Time Frame: 36 months
Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Science and Technology of the People´s Republic of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yilong Wang, MD, Beijing Tiantan Hospital
  • Principal Investigator: Zhongrong Miao, MD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017YFC1307900

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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