Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)IVUS-SCBNCT07796412
IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
A study testing IVUS-Guided Sirolimus-Coated Balloon and IVUS-Guided Sirolimus-Eluting Stent in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this interventional study is to evaluate the efficacy and safety of an intravascular ultrasound (IVUS)-guided sirolimus-coated balloon (SCB)-based strategy versus planned sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) and de novo large-vessel coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- What is being tested?
- IVUS-Guided Sirolimus-Coated Balloon and IVUS-Guided Sirolimus-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following criteria must be met:
- Aged ≥18 years.
- Diagnosed with acute coronary syndrome (ACS), including unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI). The diagnosis, classification, and clinical management of ACS will follow the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes. NSTEMI and STEMI will be diagnosed according to the Fourth Universal Definition of Myocardial Infarction.
- A de novo lesion in a large native coronary artery with a target lesion reference vessel diameter ≥2.75 mm.
- Only one target lesion is considered to require intervention and is suitable for treatment with a sirolimus-coated balloon (SCB), with bail-out stenting if necessary, or with a sirolimus-eluting stent (SES).
- Successful lesion preparation according to the prespecified angiographic and IVUS criteria, confirming that the target lesion is suitable for both randomized treatment strategies.
- The participant has fully understood the study and provided written informed consent.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Acute heart failure, acute cardiogenic shock, or persistent hemodynamic instability.
- Percutaneous coronary intervention within the previous 12 months, including stent implantation, balloon angioplasty, or SCB treatment.
- A bifurcation lesion requiring simultaneous intervention of both the main vessel and side branch.
- In-stent restenosis in the target vessel; only de novo lesions are eligible for this study.
- Lesion anatomy unsuitable for SCB treatment or conventional SES implantation, including:
Show all 22Show fewer
- Lesion length >40 mm.
- Chronic total occlusion (CTO).
- A left main coronary artery target lesion or severe left main coronary artery disease requiring simultaneous treatment.
- Severe calcification expected to preclude satisfactory lesion preparation.
- Severe vessel tortuosity or angulation >90° that may prevent safe device delivery.
- A bypass graft lesion or myocardial bridging involving the target lesion.
- Severe hepatic or renal impairment.
- A concomitant condition associated with a life expectancy of less than 1 year.
- Previous coronary artery bypass grafting (CABG).
- Unsuitable for percutaneous coronary intervention or long-term antithrombotic therapy, including:
- Known contraindication to aspirin, heparin, antiplatelet agents, or contrast media.
- A history of intracranial hemorrhage. Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Previous prosthetic heart valve replacement.
- Participation in another clinical study or clinical trial within the previous 12 months.
- Known severe hypersensitivity to sirolimus or its derivatives, any component of the study devices-including the SES polymer or metal-or contrast media; or inability or unwillingness to undergo repeat coronary angiography and IVUS at 9 months for any other reason.
- Considered unsuitable for enrollment by the investigator because of anticipated nonadherence or any other reason.
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, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Beijing, 100037
About this study
Official title: IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS: A Non-Inferiority Randomized Controlled Trial
The goal of this interventional study is to evaluate the efficacy and safety of an intravascular ultrasound (IVUS)-guided sirolimus-coated balloon (SCB)-based strategy versus planned sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) and de novo large-vessel coronary lesions. The main question is whether the SCB-based strategy is non-inferior to the SES strategy with respect to in-segment late lumen loss (LLL) at 9 months. Following adequate lesion preparation and confirmation according to the prespecified angiographic and IVUS criteria that the target lesion is suitable for both randomized treatment strategies, participants will be randomly assigned to undergo either SCB treatment without routine stent implantation or planned SES implantation. In the SCB group, bail-out SES implantation will be performed when clinically necessary, such as in cases of significant residual stenosis or flow-limiting dissection. Participants will undergo angiographic and IVUS follow-up at 9 months, and clinical outcomes will be assessed through 12 months.
Read the detailed description
Lesion preparation will be performed before randomization. Individuals with unsuccessful lesion preparation will be considered pre-randomization failures and will not be assigned to either study arm. The reason for unsuccessful lesion preparation, the treatment subsequently received, and limited safety information through 48 hours after the procedure will be documented for screening and safety oversight purposes only. These individuals will not undergo protocol-mandated follow-up and will not be included in the efficacy or comparative safety analyses of the randomized trial.
- Being tested
- IVUS-Guided Sirolimus-Coated Balloon, IVUS-Guided Sirolimus-Eluting Stent
- Keywords
- Large Vessel, Acute Coronary Syndrome, Sirolimus-Coated Balloon, Sirolimus-Eluting Stent, Intravascular Ultrasound, Non-inferiority Trial
- 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.
IVUS-Guided Sirolimus-Coated BalloonDevice
Following adequate lesion preparation and confirmation of feasibility via IVUS assessment, the SCB will be used for dilation to achieve drug delivery without routine stent implantation. In cases of significant residual stenosis or flow-limiting dissection, bail-out SES implantation will be performed. Post-procedure antithrombotic therapy and follow-up will be managed according to guideline recommendations and at the discretion of the clinician.
IVUS-Guided Sirolimus-Eluting StentDevice
Following successful lesion preparation, the SES will be implanted under IVUS guidance to optimize stent expansion and apposition. Post-procedure antithrombotic therapy and follow-up will be managed according to guideline recommendations and at the discretion of the clinician.
| Study group | Role | What they receive |
|---|---|---|
| IVUS-Guided Sirolimus-Coated Balloon | Experimental | Following successful lesion preparation, the sirolimus-coated balloon will be used for drug delivery without routine stent implantation. Bail-out sirolimus-eluting stent implantation will be performed in cases of significant residual stenosis, flow-limiting dissection, impaired coronary flow, or other prespecified indications. Participants requiring bail-out stenting will remain in the SCB group and will be analyzed according to their randomized treatment strategy. Receives: Device: IVUS-Guided Sirolimus-Coated Balloon |
| IVUS-Guided Sirolimus-Eluting Stent | Active comparator | Following successful lesion preparation, planned sirolimus-eluting stent implantation will be performed under IVUS guidance to optimize stent expansion and apposition. Receives: Device: IVUS-Guided Sirolimus-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Segment Late Lumen Loss at 9 Months
In-segment late lumen loss (LLL) of the target lesion is calculated as the in-segment minimal lumen diameter (MLD) measured immediately after the index procedure minus the in-segment MLD measured at 9-month follow-up, assessed by quantitative coronary angiography (QCA) by an independent angiographic core laboratory. The in-segment analysis region comprises the device-treated segment plus the 5 mm proximal and 5 mm distal edge segments. A negative value indicates lumen enlargement relative to the immediate post-procedural result. The mean value will be reported.
Measured: 9 months
Secondary outcomes (18)
Periprocedural Complications
A composite of cardiovascular death, periprocedural myocardial infarction, acute target lesion or target vessel thrombosis, and acute target lesion or target vessel occlusion occurring within 48 hours after the procedure.
Measured: Within 48 hours after the procedure
Target Lesion Failure (TLF)
a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).
Measured: 12 months
Patient-oriented Composite Endpoint (PoCE)
a composite of all-cause death, any myocardial infarction, any stroke, and any revascularization
Measured: 12 months
Bleeding Events
assessed according to Bleeding Academic Research Consortium (BARC) types 2-5 criteria.
Measured: 12 months
Net Adverse Clinical Events (NACE)
Time to the first occurrence of any PoCE component or BARC type 3 or 5 bleeding.
Measured: 12 months
IVUS-derived External Elastic Membrane area
Changes in IVUS-measured external elastic membrane (EEM) area within the target lesion segment from pre-procedure to post-procedure and from post-procedure to the 9-month follow-up.
Measured: Pre-procedure, immediately post-procedure, and 9 months
IVUS-derived minimum lumen area
Changes in intravascular ultrasound (IVUS)-measured minimum lumen area (MLA) from pre-procedure to post-procedure and from post-procedure to 9-month follow-up.
Measured: Pre-procedure, immediately post-procedure, and 9 months
IVUS-derived plaque burden
Changes in intravascular ultrasound (IVUS)-measured plaque burden from pre-procedure to post-procedure and from post-procedure to 9-month follow-up.
Measured: Pre-procedure, immediately post-procedure, and 9 months
Minimum lumen diameter
Target lesion segment minimum lumen diameter (MLD) measured by quantitative coronary angiography (QCA) before lesion preparation, immediately after the procedure, and at 9-month follow-up.
Measured: Pre-procedure, immediately post-procedure, and 9 months
Percent diameter stenosis
Target lesion segment percent diameter stenosis (%DS) measured by QCA before lesion preparation, immediately after the procedure, and at 9-month follow-up.
Measured: Pre-procedure, immediately post-procedure, and 9 months
Binary restenosis
Proportion of participants with target lesion segment %DS ≥50% at 9-month follow-up, as assessed by QCA
Measured: 9 months
Acute lumen gain
Acute lumen gain, calculated as post-procedure MLD minus pre-procedure MLD.
Measured: Immediately post-procedure
Net lumen gain
Net lumen gain, calculated as 9-month MLD minus pre-procedure MLD.
Measured: 9 months
Late lumen enlargement
In-segment late lumen enlargement (LLE) is defined as an in-segment late lumen loss (LLL) value less than 0 mm. In-segment LLL is calculated as the in-segment minimal lumen diameter (MLD) measured immediately after the index procedure minus the in-segment MLD measured at 9-month follow-up, assessed by quantitative coronary angiography (QCA) by an independent angiographic core laboratory. The in-segment analysis region comprises the device-treated segment plus the 5 mm proximal and 5 mm distal edge segments. A negative LLL value indicates lumen enlargement relative to the immediate post-procedural result. Each participant is classified as having LLE or not; a single value - the percentage of participants meeting this criterion - will be reported.
Measured: 9 months
Length of Index Hospital Stay
Length of stay for the index hospitalization, defined as the number of days from admission to discharge for the procedure hospitalization.
Measured: From admission to discharge for the index hospitalization
Percentage of Participants With Cardiovascular-Related Rehospitalization
The percentage of participants with at least one unplanned rehospitalization for a cardiovascular cause after discharge from the index hospitalization. Each participant is counted only once regardless of the number of rehospitalizations.
Measured: 12 months
Percentage of Participants With Repeat Coronary Revascularization
The percentage of participants undergoing any repeat coronary revascularization, including percutaneous coronary intervention or coronary artery bypass grafting, of any vessel after the index procedure. Each participant is counted only once regardless of the number of procedures.
Measured: 12 months
Cumulative Cardiovascular-Related Direct Medical Costs
Cumulative direct medical costs related to cardiovascular care, including the index procedure, index hospitalization, rehospitalizations, and repeat revascularization procedures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jan 2029 (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) Undergoing Percutaneous Coronary Intervention (PCI)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
- Model description
- Following informed consent, potentially eligible participants will undergo lesion preparation before randomization. Only participants with successful lesion preparation according to the prespecified angiographic and intravascular ultrasound (IVUS) criteria, confirming that the target lesion is suitable for both randomized treatment strategies, will be randomized in a 1:1 ratio to either the IVUS-guided sirolimus-coated balloon (SCB)-based strategy or planned sirolimus-eluting stent (SES) implantation. Participants with unsuccessful lesion preparation will not undergo randomization, will not be counted toward the planned enrollment of 150 randomized participants, and will not be included in the outcome analyses of the randomized trial. Participants randomized to the SCB group who require bail-out SES implantation according to prespecified criteria will remain in the SCB group and will be analyzed according to their randomized treatment strategy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- B. Braun Medical International Trading Company Ltd.
- Responsible party
- Principal investigator, Erli Zhang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796412
- Sponsor's protocol ID
- FW-ZEL-002
- Acronym
- IVUS-SCB
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval of a methodologically sound research proposal, subject to an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS: A Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07796412
- Acronym / sponsor ID
- IVUS-SCB / FW-ZEL-002
- Keywords
- Large Vessel, Acute Coronary Syndrome, Sirolimus-Coated Balloon, Sirolimus-Eluting Stent, Intravascular Ultrasound, Non-inferiority Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- B. Braun Medical International Trading Company Ltd.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 1 Sep 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.
The goal of this interventional study is to evaluate the efficacy and safety of an intravascular ultrasound (IVUS)-guided sirolimus-coated balloon (SCB)-based strategy versus planned sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) and de novo large-vessel coronary lesions. The main question is whether the SCB-based strategy is non-inferior to the SES strategy with respect to in-segment late lumen loss (LLL) at 9 months. Following adequate lesion preparation and confirmation according to the prespecified angiographic and IVUS criteria that the target lesion is suitable for both randomized treatment strategies, participants will be randomly assigned to undergo either SCB treatment without routine stent implantation or planned SES implantation. In the SCB group, bail-out SES implantation will be performed when clinically necessary, such as in cases of significant residual stenosis or flow-limiting dissection. Participants will undergo angiographic and IVUS follow-up at 9 months, and clinical outcomes will be assessed through 12 months.
Detailed description
Lesion preparation will be performed before randomization. Individuals with unsuccessful lesion preparation will be considered pre-randomization failures and will not be assigned to either study arm. The reason for unsuccessful lesion preparation, the treatment subsequently received, and limited safety information through 48 hours after the procedure will be documented for screening and safety oversight purposes only. These individuals will not undergo protocol-mandated follow-up and will not be included in the efficacy or comparative safety analyses of the randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Following informed consent, potentially eligible participants will undergo lesion preparation before randomization. Only participants with successful lesion preparation according to the prespecified angiographic and intravascular ultrasound (IVUS) criteria, confirming that the target lesion is suitable for both randomized treatment strategies, will be randomized in a 1:1 ratio to either the IVUS-guided sirolimus-coated balloon (SCB)-based strategy or planned sirolimus-eluting stent (SES) implantation. Participants with unsuccessful lesion preparation will not undergo randomization, will not be counted toward the planned enrollment of 150 randomized participants, and will not be included in the outcome analyses of the randomized trial. Participants randomized to the SCB group who require bail-out SES implantation according to prespecified criteria will remain in the SCB group and will be analyzed according to their randomized treatment strategy.
| Arm | Type | Receives |
|---|---|---|
| IVUS-Guided Sirolimus-Coated Balloon | Experimental | Device: IVUS-Guided Sirolimus-Coated BalloonFollowing successful lesion preparation, the sirolimus-coated balloon will be used for drug delivery without routine stent implantation. Bail-out sirolimus-eluting stent implantation will be performed in cases of significant residual stenosis, flow-limiting dissection, impaired coronary flow, or other prespecified indications. Participants requiring bail-out stenting will remain in the SCB group and will be analyzed according to their randomized treatment strategy. |
| IVUS-Guided Sirolimus-Eluting Stent | Active comparator | Device: IVUS-Guided Sirolimus-Eluting StentFollowing successful lesion preparation, planned sirolimus-eluting stent implantation will be performed under IVUS guidance to optimize stent expansion and apposition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years.
- Diagnosed with acute coronary syndrome (ACS), including unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI). The diagnosis, classification, and clinical management of ACS will follow the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes. NSTEMI and STEMI will be diagnosed according to the Fourth Universal Definition of Myocardial Infarction.
- A de novo lesion in a large native coronary artery with a target lesion reference vessel diameter ≥2.75 mm.
- Only one target lesion is considered to require intervention and is suitable for treatment with a sirolimus-coated balloon (SCB), with bail-out stenting if necessary, or with a sirolimus-eluting stent (SES).
- Successful lesion preparation according to the prespecified angiographic and IVUS criteria, confirming that the target lesion is suitable for both randomized treatment strategies.
Key exclusion criteria (22 listed)
- Acute heart failure, acute cardiogenic shock, or persistent hemodynamic instability.
- Percutaneous coronary intervention within the previous 12 months, including stent implantation, balloon angioplasty, or SCB treatment.
- A bifurcation lesion requiring simultaneous intervention of both the main vessel and side branch.
- In-stent restenosis in the target vessel; only de novo lesions are eligible for this study.
- Lesion anatomy unsuitable for SCB treatment or conventional SES implantation, including:
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 |
|---|---|---|
| IVUS-Guided Sirolimus-Coated BalloonFollowing adequate lesion preparation and confirmation of feasibility via IVUS assessment, the SCB will be used for dilation to achieve drug delivery without routine stent implantation. In cases of significant residual stenosis or flow-limiting dissection, bail-out SES implantation will be performed. Post-procedure antithrombotic therapy and follow-up will be managed according to guideline recommendations and at the discretion of the clinician. | Device | IVUS-Guided Sirolimus-Coated Balloon |
| IVUS-Guided Sirolimus-Eluting StentFollowing successful lesion preparation, the SES will be implanted under IVUS guidance to optimize stent expansion and apposition. Post-procedure antithrombotic therapy and follow-up will be managed according to guideline recommendations and at the discretion of the clinician. | Device | IVUS-Guided Sirolimus-Eluting Stent |
Primary outcome
In-Segment Late Lumen Loss at 9 Months
Time frame: 9 months
In-segment late lumen loss (LLL) of the target lesion is calculated as the in-segment minimal lumen diameter (MLD) measured immediately after the index procedure minus the in-segment MLD measured at 9-month follow-up, assessed by quantitative coronary angiography (QCA) by an independent angiographic core laboratory. The in-segment analysis region comprises the device-treated segment plus the 5 mm proximal and 5 mm distal edge segments. A negative value indicates lumen enlargement relative to the immediate post-procedural result. The mean value will be reported.
18 secondary outcomes
Periprocedural Complications
Time frame: Within 48 hours after the procedure
Target Lesion Failure (TLF)
Time frame: 12 months
Patient-oriented Composite Endpoint (PoCE)
Time frame: 12 months
Bleeding Events
Time frame: 12 months
Net Adverse Clinical Events (NACE)
Time frame: 12 months
IVUS-derived External Elastic Membrane area
Time frame: Pre-procedure, immediately post-procedure, and 9 months
IVUS-derived minimum lumen area
Time frame: Pre-procedure, immediately post-procedure, and 9 months
IVUS-derived plaque burden
Time frame: Pre-procedure, immediately post-procedure, and 9 months
Minimum lumen diameter
Time frame: Pre-procedure, immediately post-procedure, and 9 months
Percent diameter stenosis
Time frame: Pre-procedure, immediately post-procedure, and 9 months
Binary restenosis
Time frame: 9 months
Acute lumen gain
Time frame: Immediately post-procedure
Net lumen gain
Time frame: 9 months
Late lumen enlargement
Time frame: 9 months
Length of Index Hospital Stay
Time frame: From admission to discharge for the index hospitalization
Percentage of Participants With Cardiovascular-Related Rehospitalization
Time frame: 12 months
Percentage of Participants With Repeat Coronary Revascularization
Time frame: 12 months
Cumulative Cardiovascular-Related Direct Medical Costs
Time frame: 12 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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval of a methodologically sound research proposal, subject to an appropriate data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-Guided Sirolimus-Coated Balloon and IVUS-Guided Sirolimus-Eluting Stent in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), 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 7 inclusion and 22 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 15 Oct 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 Erli Zhang (+86 13621010047, zhangerli@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Segment Late Lumen Loss at 9 Months (time frame: 9 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 15 Oct 2026.