Acute Coronary Syndromes (ACS)NCT07514988
Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment
A study testing Sirolimus-coated DCB and Paclitaxel-coated DCB in people with Acute Coronary Syndromes (ACS), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- Sirolimus-coated DCB and Paclitaxel-coated DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled:
- Age between 18 and 80 years old, both genders eligible;
- Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
- Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
- Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
- Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Total occlusion (TIMI 0 flow) lesion;
- In-stent restenosis lesion;
- Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
- Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
- Coronary artery bypass graft stenosis;
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- Confirmed ST-elevation myocardial infarction;
- Cardiogenic shock or requiring mechanical respiratory and circulatory support;
- Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
- Severe renal insufficiency or undergoing hemodialysis;
- Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
- Systemic lupus erythematosus or other systemic autoimmune diseases;
- History of stroke within 6 months prior to enrollment;
- Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
- Currently participating in other drug or interventional medical device clinical studies;
- Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
Jie Zhao, +8613911036089, fwzhaojie@126.com
About this study
Official title: Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
Read the detailed description
This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).
- Conditions
- Acute Coronary Syndromes (ACS)
- Being tested
- Sirolimus-coated DCB, Paclitaxel-coated DCB
- 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.
Sirolimus-coated DCBDevice
Treatment of sirolimus-coated DCB
Paclitaxel-coated DCBDevice
Treatment of paclitaxel-coated DCB
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-coated DCB group | Experimental | Treatment of sirolimus-coated DCB Receives: Device: Sirolimus-coated DCB |
| Paclitaxel-coated DCB | Active comparator | Treatment of paclitaxel-coated DCB Receives: Device: Paclitaxel-coated DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT <75μm, (2) maximum lipid arc >180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.
Measured: 3 months
Secondary outcomes (13)
OCT-measured minimum lumen area change at 3 months post-procedure
Change in minimum lumen area (MLA) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm².
Measured: 3 months
OCT-measured fibrous cap thickness change at 3 months post-procedure
Change in fibrous cap thickness (FCT) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: μm.
Measured: 3 months
OCT-measured maximum lipid arc change at 3 months post-procedure
Change in maximum lipid arc measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: degrees.
Measured: 3 months
OCT assessment of macrophage infiltration change at 3 months post-procedure
Change in macrophage infiltration presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.
Measured: 3 months
OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure
Change in number of thin-cap fibroatheroma (TCFA) lesions measured by optical coherence tomography from baseline to 3 months post-procedure. TCFA defined as lipid-rich plaque with fibrous cap thickness <65μm. Unit: count.
Measured: 3 months
OCT-measured lipid pool length change at 3 months post-procedure
Change in lipid pool length measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.
Measured: 3 months
OCT assessment of microchannel change at 3 months post-procedure
Change in microchannel presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.
Measured: 3 months
OCT-measured minimum lumen diameter change at 3 months post-procedure
Change in minimum lumen diameter measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.
Measured: 3 months
CCTA-measured perivascular fat attenuation index change at 6 months
Change in perivascular fat attenuation index (FAI) measured by coronary computed tomography angiography from baseline to 6 months post-procedure. FAI is defined as the mean CT attenuation value of perivascular adipose tissue surrounding the coronary artery. Unit: Hounsfield Units (HU).
Measured: 6 months
CCTA-measured low-attenuation plaque volume change at 6 months post-procedure
Change in low-attenuation plaque volume measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Low-attenuation plaque is defined as plaque with CT value <30 HU. Unit: mm³.
Measured: 6 months
CCTA-measured plaque burden change at 6 months post-procedure
Change in plaque burden measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Plaque burden is calculated as plaque volume divided by total vessel volume multiplied by 100%. Unit: percentage (%).
Measured: 6 months
Incidence of target lesion failure (TLF) at 6 months post-procedure
Target lesion failure (TLF) was defined as a composite endpoint consisting of cardiovascular death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization.
Measured: 6 months
Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure
Patient-oriented composite endpoint (PoCE) was defined as a composite of all-cause death, any stroke, any myocardial infarction, and any revascularization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jie Zhao, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514988
- Sponsor's protocol ID
- RWT-P/S-001
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07514988
- Acronym / sponsor ID
- RWT-P/S-001
- Conditions
- Acute Coronary Syndromes (ACS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
Detailed description
This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-coated DCB group | Experimental | Device: Sirolimus-coated DCBTreatment of sirolimus-coated DCB |
| Paclitaxel-coated DCB | Active comparator | Device: Paclitaxel-coated DCBTreatment of paclitaxel-coated DCB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years old, both genders eligible;
- Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
- Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
- Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
- Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.
Key exclusion criteria (16 listed)
- Total occlusion (TIMI 0 flow) lesion;
- In-stent restenosis lesion;
- Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
- Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
- Coronary artery bypass graft stenosis;
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 |
|---|---|---|
| Sirolimus-coated DCBTreatment of sirolimus-coated DCB | Device | Sirolimus-coated DCB group |
| Paclitaxel-coated DCBTreatment of paclitaxel-coated DCB | Device | Paclitaxel-coated DCB |
Primary outcome
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
Time frame: 3 months
OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT <75μm, (2) maximum lipid arc >180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.
13 secondary outcomes
OCT-measured minimum lumen area change at 3 months post-procedure
Time frame: 3 months
OCT-measured fibrous cap thickness change at 3 months post-procedure
Time frame: 3 months
OCT-measured maximum lipid arc change at 3 months post-procedure
Time frame: 3 months
OCT assessment of macrophage infiltration change at 3 months post-procedure
Time frame: 3 months
OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure
Time frame: 3 months
OCT-measured lipid pool length change at 3 months post-procedure
Time frame: 3 months
OCT assessment of microchannel change at 3 months post-procedure
Time frame: 3 months
OCT-measured minimum lumen diameter change at 3 months post-procedure
Time frame: 3 months
CCTA-measured perivascular fat attenuation index change at 6 months
Time frame: 6 months
CCTA-measured low-attenuation plaque volume change at 6 months post-procedure
Time frame: 6 months
CCTA-measured plaque burden change at 6 months post-procedure
Time frame: 6 months
Incidence of target lesion failure (TLF) at 6 months post-procedure
Time frame: 6 months
Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure
Time frame: 6 months
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 7 Apr 2026.
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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.
Jie Zhao, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-coated DCB and Paclitaxel-coated DCB in people with Acute Coronary Syndromes (ACS), run by China National Center for Cardiovascular Diseases at 1 site 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 6 inclusion and 16 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jie Zhao, MD, PhD (+8613911036089, fwzhaojie@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure (time frame: 3 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 7 Apr 2026.