IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS

N/ANot Yet RecruitingNCT07796412

China National Center for Cardiovascular Diseases150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.