An interventional study of IVUS-Guided Sirolimus-Coated Balloon and IVUS-Guided Sirolimus-Eluting Stent in Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
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Among 185 studies in Acute Coronary Syndrome with a site in China — 56 open to participants now, 63 under way, 3 of them phase 3. Acute Coronary Syndrome · China.
Among the 185 studies in Acute Coronary Syndrome with a site in China, this one is the 87th largest by planned enrollment of the 115 interventional ones that give a count, is one of 10 that started in 2026, is one of 47 with no phase, reaches primary completion later than 57 of the 62 other live ones, and was the 183rd registered.
1,490 studies on the registry are indexed under Acute Coronary Syndrome; 272 are open to participants now.
Browse Acute Coronary Syndrome studies →56 of the 185 studies in Acute Coronary Syndrome with a site in China are open now. Recruiting first, the newest first:
Shenyang Northern Hospital · Sites in China
Ages 18+
Xiling Qi · Sites in China
Ages up to 85
Jilin University · Sites in China
Ages 18–85
Jing Han · Sites in China
Ages 18+
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 196 Acute Coronary Syndrome studies recruiting now, 145 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 15 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 2 · Phase 3 14 · Phase 4 47
First in 2005; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is below the median of 200 across 867 interventional studies indexed under Acute Coronary Syndrome.
Median enrollment 499 across the 115 interventional studies, 1,312 across the 70 observational. Of the 67 that completed or were terminated, 12 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 185 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 270 studies on the registry; 142 are open to participants now.
China National Center for Cardiovascular Diseases has 6 studies filed under Acute Coronary Syndrome — fewer than ten, so there is no comparison to draw.
18 of the studies in Acute Coronary Syndrome with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06577519Phase 3Jiangsu vcare pharmaceutical technology co., LTDEfficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) | 2026-12-30 |
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT05325034Stephen NichollsGuideline Oriented Approach To Lipid Lowering In Asia-Pacific | 2026-12 |
| NCT05638867China National Center for Cardiovascular DiseasesNOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI | 2026-12 |
| NCT05457582Nanjing First Hospital, Nanjing Medical UniversityPCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI | 2026-12-30 |
Add all 18 to your calendar (.ics) → With an account.
Among the 185 studies in Acute Coronary Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All of the following criteria must be met:
Exclusion Criteria
Participants meeting any of the following criteria will be excluded:
i. Lesion length >40 mm.
ii. Chronic total occlusion (CTO).
iii. A left main coronary artery target lesion or severe left main coronary artery disease requiring simultaneous treatment.
iv. Severe calcification expected to preclude satisfactory lesion preparation.
v. Severe vessel tortuosity or angulation >90° that may prevent safe device delivery.
vi. A bypass graft lesion or myocardial bridging involving the target lesion.
f. Severe hepatic or renal impairment.
g. A concomitant condition associated with a of less than 1 year.
h. Previous coronary artery bypass grafting (CABG).
i. Unsuitable for percutaneous coronary intervention or long-term antithrombotic therapy, including:
Known to aspirin, heparin, antiplatelet agents, or contrast media.
A history of intracranial hemorrhage. Pregnancy, breastfeeding, or planned pregnancy during the study period.
j. Previous prosthetic heart valve replacement.
k. Participation in another clinical study or clinical trial within the previous 12 months.
l. Known severe 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.
m. Considered unsuitable for enrollment by the investigator because of anticipated nonadherence or any other reason.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: IVUS-Guided Sirolimus-Coated Balloon
Following successful lesion preparation, planned sirolimus-eluting stent implantation will be performed under IVUS guidance to optimize stent expansion and apposition.
Device: IVUS-Guided Sirolimus-Eluting Stent
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.
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.
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.
Time frame: 9 months
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.
Time frame: 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).
Time frame: 12 months
Patient-oriented Composite Endpoint (PoCE)
a composite of all-cause death, any myocardial infarction, any stroke, and any revascularization
Time frame: 12 months
Bleeding Events
assessed according to Bleeding Academic Research Consortium (BARC) types 2-5 criteria.
Time frame: 12 months
Net Adverse Clinical Events (NACE)
Time to the first occurrence of any PoCE component or BARC type 3 or 5 bleeding.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 9 months
Acute lumen gain
Acute lumen gain, calculated as post-procedure MLD minus pre-procedure MLD.
Time frame: Immediately post-procedure
Net lumen gain
Net lumen gain, calculated as 9-month MLD minus pre-procedure MLD.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 36 months after publication of the primary study results and continuing for 5 years.
Access criteria: Deidentified individual participant data underlying the results reported in the primary publication will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators and, where applicable, relevant institutional or ethics authorities. Proposals that substantially overlap with prespecified ongoing analyses may be deferred until completion of those analyses. Data will be provided for the purposes specified in the approved proposal, subject to an appropriate data use agreement and applicable privacy and data protection requirements.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 213 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 24 months is below that.
Counting every sponsor, half of 228 studies reached it within 34 months; a quarter within 17 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: start Sep 2026 → Dec 2026, primary completion Dec 2027 → Dec 2028 and completion May 2028 → Jan 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases →