Acute Coronary Syndrome (ACS)NCT06365502
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
A study testing Drug-coated balloon and Guideline-directed medical treatment in people with Acute Coronary Syndrome (ACS), run by Harbin Medical University at 18 sites in China.
Trial summary
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Drug-coated balloon and Guideline-directed medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,860 participants
- Where
- 18 sitesChina
- Study dates
- 16 Apr 2024to Dec 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between 18 and 80 years of age
- Subject must present with acute myocardial infarction or unstable angina planned for PCI
- Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
- Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
- Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
- Target lesion must have any two of the intravascular imaging criteria of PB >65%, MLA <3.5 mm^2 (OCT) or 4.0mm^2 (IVUS), FCT <75 μm, or maximal lipid arc >180°
- Subject must provide written informed consent before any study-related procedure
Who cannot join
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
- Hypotension, shock, or need for mechanical support or intravenous vasopressors;
- Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR)
- Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
- Life expectancy <2 years for any
Show all 14Show fewer
- Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- The target lesion is located within 10 mm of the proximal or distal of stent
- The target lesion cannot be in the left main coronary artery
- The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
- The target lesion is located in severe calcification or tortuosity of vessels
- The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
- The target lesion is located within the bypass graft artery
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
Affiliated Beijing Luhe Hospital of Capital Medical University
Beijin, Beijing Municipality, 101149
Guangyao zhai
Guangyao zhai
- Not yet recruiting
The Third Second Hospital of Jilin University
Changchun, Jilin, 132000
Bin Liu
Bin Liu
- Not yet recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning, 116000
Xiaoqun Zheng
Xiaoqun Zheng
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Bo Zhang
Bo Zhang
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 150000
Zhiqi Sun
Zhiqi Sun
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Haibo Jia, PhD
Bo Yu, PhD
- Not yet recruiting
The Affiliated Hospital of Neimenggu Medical University
Hohhot, Neimenggu, 011500
Fengying Chen
Fengying Chen
- Not yet recruiting
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 150000
Guangyuan Yang
Guangyuan Yang
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
Haitao Yuan
Haitao Yuan
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 250000
Lijun Gan
Lijun Gan
- Not yet recruiting
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, 150000
Kai Liu
Kai Liu
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 250000
Peng Li
Peng Li
- Not yet recruiting
The People's Hospital of Liaoning Province
Shengyang, Liaoning, 132000
Bo Luan
Bo Luan
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430022
Xiang Chen
Xiang Chen
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 250000
Lin Zhong
Lin Zhong
- Not yet recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Xiaohui Zheng
Xiaohui Zheng
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Chunguang Qiu
Chunguang Qiu
- Not yet recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Ranzun Zhao
Ranzun Zhao
About this study
Official title: A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Drug-coated balloon, Guideline-directed medical treatment
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloonDevice
Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.
Guideline-directed medical treatmentDrug
All individuals will receive guideline-directed medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| DCB treatment | Experimental | Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment. Receives: Device: Drug-coated balloon; Drug: Guideline-directed medical treatment |
| Guideline-directed medical treatment | Active comparator | Non-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone. Receives: Drug: Guideline-directed medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure (TLF)
Measured: At 24 months
Secondary outcomes (45)
Target lesion failure (TLF)
Measured: At 30 days
Target lesion failure (TLF)
Measured: At 6 months
Target lesion failure (TLF)
Measured: At 12 months
Major cardiac adverse event (MACE)
MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina
Measured: At 30 days
Major cardiac adverse event (MACE)
MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina
Measured: At 6 months
Major cardiac adverse event (MACE)
MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina
Measured: At 12 months
Major cardiac adverse event (MACE)
MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina
Measured: At 24 months
All-cause death
Any death will be recorded as all-cause death
Measured: At 30 days
All-cause death
Any death will be recorded as all-cause death
Measured: At 6 months
All-cause death
Any death will be recorded as all-cause death
Measured: At 12 months
All-cause death
Any death will be recorded as all-cause death
Measured: At 24 months
Cardiac death and target lesion MI
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 30 days
Cardiac death and target lesion MI
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 6 months
Cardiac death and target lesion MI
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 12 months
Cardiac death and target lesion MI
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 24 months
Cardiac death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 30 days
Cardiac death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 6 months
Cardiac death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 12 months
Cardiac death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Measured: At 24 months
Target lesion myocardial infarction
Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed
Measured: At 30 days
Target lesion myocardial infarction
Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed
Measured: At 6 months
Target lesion myocardial infarction
Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed
Measured: At 12 months
Target lesion myocardial infarction
Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed
Measured: At 24 months
Periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.
Measured: At 30 days
Periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.
Measured: At 6 months
Periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.
Measured: At 12 months
Periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.
Measured: At 24 months
Periprocedural and non-periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed
Measured: At 30 days
Periprocedural and non-periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed
Measured: At 6 months
Periprocedural and non-periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed
Measured: At 12 months
Periprocedural and non-periprocedural myocardial infarction
Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed
Measured: At 24 months
Target vessel failure (TVF)
TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.
Measured: At 30 days
Target vessel failure (TVF)
TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.
Measured: At 6 months
Target vessel failure (TVF)
TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.
Measured: At 12 months
Target vessel failure (TVF)
TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.
Measured: At 24 months
Minimal lumen area after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
Plaque burden after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
FCT after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
Lipid arc after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
FCT <75 μm after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
PB >65% after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
PB >70% after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
MLA <3.5 mm^2 after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
Maximal lipid arc >180° after DCB treatment
Post-procedure imaging examination is required
Measured: At baseline
Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc.
The centers with sample preservation qualifications will be asked to preserve blood samples.
Measured: At baseline and one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start16 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shenqi Medical Technology Co., Ltd
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365502
- Sponsor's protocol ID
- KY2023-156
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
- ClinicalTrials.gov ID
- NCT06365502
- Acronym / sponsor ID
- KY2023-156
- Conditions
- Acute Coronary Syndrome (ACS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,860 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Shenqi Medical Technology Co., Ltd
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB treatment | Experimental | Device: Drug-coated balloon, Drug: Guideline-directed medical treatmentNon-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment. |
| Guideline-directed medical treatment | Active comparator | Drug: Guideline-directed medical treatmentNon-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be between 18 and 80 years of age
- Subject must present with acute myocardial infarction or unstable angina planned for PCI
- Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
- Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
- Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
Key exclusion criteria (14 listed)
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
- Hypotension, shock, or need for mechanical support or intravenous vasopressors;
- Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR)
- Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-coated balloonNon-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed. | Device | DCB treatment |
| Guideline-directed medical treatmentAll individuals will receive guideline-directed medical treatment. | Drug | DCB treatment, Guideline-directed medical treatment |
Primary outcome
Target lesion failure (TLF)
Time frame: At 24 months
45 secondary outcomes
Target lesion failure (TLF)
Time frame: At 30 days
Target lesion failure (TLF)
Time frame: At 6 months
Target lesion failure (TLF)
Time frame: At 12 months
Major cardiac adverse event (MACE)
Time frame: At 30 days
Major cardiac adverse event (MACE)
Time frame: At 6 months
Major cardiac adverse event (MACE)
Time frame: At 12 months
Major cardiac adverse event (MACE)
Time frame: At 24 months
All-cause death
Time frame: At 30 days
All-cause death
Time frame: At 6 months
All-cause death
Time frame: At 12 months
All-cause death
Time frame: At 24 months
Cardiac death and target lesion MI
Time frame: At 30 days
Cardiac death and target lesion MI
Time frame: At 6 months
Cardiac death and target lesion MI
Time frame: At 12 months
Cardiac death and target lesion MI
Time frame: At 24 months
Cardiac death
Time frame: At 30 days
Cardiac death
Time frame: At 6 months
Cardiac death
Time frame: At 12 months
Cardiac death
Time frame: At 24 months
Target lesion myocardial infarction
Time frame: At 30 days
Target lesion myocardial infarction
Time frame: At 6 months
Target lesion myocardial infarction
Time frame: At 12 months
Target lesion myocardial infarction
Time frame: At 24 months
Periprocedural myocardial infarction
Time frame: At 30 days
Periprocedural myocardial infarction
Time frame: At 6 months
Periprocedural myocardial infarction
Time frame: At 12 months
Periprocedural myocardial infarction
Time frame: At 24 months
Periprocedural and non-periprocedural myocardial infarction
Time frame: At 30 days
Periprocedural and non-periprocedural myocardial infarction
Time frame: At 6 months
Periprocedural and non-periprocedural myocardial infarction
Time frame: At 12 months
Periprocedural and non-periprocedural myocardial infarction
Time frame: At 24 months
Target vessel failure (TVF)
Time frame: At 30 days
Target vessel failure (TVF)
Time frame: At 6 months
Target vessel failure (TVF)
Time frame: At 12 months
Target vessel failure (TVF)
Time frame: At 24 months
Minimal lumen area after DCB treatment
Time frame: At baseline
Plaque burden after DCB treatment
Time frame: At baseline
FCT after DCB treatment
Time frame: At baseline
Lipid arc after DCB treatment
Time frame: At baseline
FCT <75 μm after DCB treatment
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Yu, PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-coated balloon and Guideline-directed medical treatment in people with Acute Coronary Syndrome (ACS), run by Harbin Medical University at 18 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 Haibo Jia, PhD (15945685291, jhb101180@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (TLF) (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2024.