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

NCT07796412 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Interventions

DEVICE

IVUS-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.

DEVICE

IVUS-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 & Collaborators

  • B. Braun Medical International Trading Company Ltd.

    collaborator INDUSTRY

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2028-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796412 on ClinicalTrials.gov