Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Large Vessel, Acute Coronary Syndrome, Sirolimus-Coated Balloon, Sirolimus-Eluting Stent, Intravascular Ultrasound, Non-inferiority Trial
Brief 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. 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.
Interventions
DEVICEIVUS-Guided Sirolimus-Coated Balloon
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.
DEVICEIVUS-Guided Sirolimus-Eluting Stent
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.
Sponsors
China National Center for Cardiovascular Diseases
B. Braun Medical International Trading Company Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating physicians are not masked. Clinical endpoints are adjudicated by an independent Clinical Events Committee blinded to treatment allocation. The statistical team will remain blinded to coded treatment groups until database lock. Angiographic and IVUS assessments will be performed by an independent core laboratory; however, complete masking of the core laboratory is not feasible because stent implantation is visible on the images.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following criteria must be met: 1. Aged ≥18 years. 2. 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. 3. A de novo lesion in a large native coronary artery with a target lesion reference vessel diameter ≥2.75 mm. 4. 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). 5. Successful lesion preparation according to the prespecified angiographic and IVUS criteria, confirming that the target lesion is suitable for both randomized treatment strategies. 6. The participant has fully understood the study and provided written informed consent.
Exclusion criteria
Participants meeting any of the following criteria will be excluded: 1. Acute heart failure, acute cardiogenic shock, or persistent hemodynamic instability. 2. Percutaneous coronary intervention within the previous 12 months, including stent implantation, balloon angioplasty, or SCB treatment. 3. A bifurcation lesion requiring simultaneous intervention of both the main vessel and side branch. 4. In-stent restenosis in the target vessel; only de novo lesions are eligible for this study. 5. Lesion anatomy unsuitable for SCB treatment or conventional SES implantation, including: 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 life expectancy 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 contraindication 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 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. m. Considered unsuitable for enrollment by the investigator because of anticipated nonadherence or any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Segment Late Lumen Loss at 9 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Complications | Within 48 hours after the procedure | 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. |
| Target Lesion Failure (TLF) | 12 months | a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). |
| Patient-oriented Composite Endpoint (PoCE) | 12 months | a composite of all-cause death, any myocardial infarction, any stroke, and any revascularization |
| Bleeding Events | 12 months | assessed according to Bleeding Academic Research Consortium (BARC) types 2-5 criteria. |
| Net Adverse Clinical Events (NACE) | 12 months | Time to the first occurrence of any PoCE component or BARC type 3 or 5 bleeding. |
| IVUS-derived External Elastic Membrane area | Pre-procedure, immediately post-procedure, and 9 months | 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. |
| IVUS-derived minimum lumen area | Pre-procedure, immediately post-procedure, and 9 months | 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. |
| IVUS-derived plaque burden | Pre-procedure, immediately post-procedure, and 9 months | Changes in intravascular ultrasound (IVUS)-measured plaque burden from pre-procedure to post-procedure and from post-procedure to 9-month follow-up. |
| Minimum lumen diameter | Pre-procedure, immediately post-procedure, and 9 months | 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. |
| Percent diameter stenosis | Pre-procedure, immediately post-procedure, and 9 months | Target lesion segment percent diameter stenosis (%DS) measured by QCA before lesion preparation, immediately after the procedure, and at 9-month follow-up. |
| Binary restenosis | 9 months | Proportion of participants with target lesion segment %DS ≥50% at 9-month follow-up, as assessed by QCA |
| Acute lumen gain | Immediately post-procedure | Acute lumen gain, calculated as post-procedure MLD minus pre-procedure MLD. |
| Net lumen gain | 9 months | Net lumen gain, calculated as 9-month MLD minus pre-procedure MLD. |
| Late lumen enlargement | 9 months | 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. |
| Length of Index Hospital Stay | From admission to discharge for the index hospitalization | Length of stay for the index hospitalization, defined as the number of days from admission to discharge for the procedure hospitalization. |
| Percentage of Participants With Cardiovascular-Related Rehospitalization | 12 months | 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. |
| Percentage of Participants With Repeat Coronary Revascularization | 12 months | 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. |
| Cumulative Cardiovascular-Related Direct Medical Costs | 12 months | Cumulative direct medical costs related to cardiovascular care, including the index procedure, index hospitalization, rehospitalizations, and repeat revascularization procedures. |
Countries
China
Contacts
CONTACTErli Zhang
Outcome results
None listed