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.
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).
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.
Parallel
IVUS-Guided Sirolimus-Coated Balloon
DeviceFollowing 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 Stent
DeviceFollowing 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.
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.
Target Lesion Failure (TLF)
a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).
Patient-oriented Composite Endpoint (PoCE)
a composite of all-cause death, any myocardial infarction, any stroke, and any revascularization
Bleeding Events
assessed according to Bleeding Academic Research Consortium (BARC) types 2-5 criteria.
Click on the lead sponsor to view all of their trials.
China National Center for Cardiovascular Diseases
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
B. Braun Medical International Trading Company Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
