Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

Comparison Study of Sirolimus-Coated Versus Paclitaxel-Coated Coronary Drug-Coated Balloons in the Treatment of Acute Coronary Syndrome

This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndromes (ACS)
• Intervention / Treatment: Device: Sirolimus-coated DCB; Device: Paclitaxel-coated DCB

Detailed Description

This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Zhao, MD, PhD; Phone Number: +8613911036089; Email: fwzhaojie@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Fuwai Hospital, CAMS&PUMC
      • Contact: Jie Zhao; Phone Number: +8613911036089; Email: fwzhaojie@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled:

1. Age between 18 and 80 years old, both genders eligible;
2. Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
4. Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

1. Total occlusion (TIMI 0 flow) lesion;
2. In-stent restenosis lesion;
3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
5. Coronary artery bypass graft stenosis;
6. Confirmed ST-elevation myocardial infarction;
7. Cardiogenic shock or requiring mechanical respiratory and circulatory support;
8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
9. Severe renal insufficiency or undergoing hemodialysis;
10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
11. Systemic lupus erythematosus or other systemic autoimmune diseases;
12. History of stroke within 6 months prior to enrollment;
13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
14. Currently participating in other drug or interventional medical device clinical studies;
15. Other conditions deemed unsuitable for enrollment by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus-coated DCB group; Treatment of sirolimus-coated DCB	Device: Sirolimus-coated DCB; Treatment of sirolimus-coated DCB
Active Comparator: Paclitaxel-coated DCB; Treatment of paclitaxel-coated DCB	Device: Paclitaxel-coated DCB; Treatment of paclitaxel-coated DCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure	OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT <75μm, (2) maximum lipid arc >180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCT-measured minimum lumen area change at 3 months post-procedure	Change in minimum lumen area (MLA) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm².	3 months
OCT-measured fibrous cap thickness change at 3 months post-procedure	Change in fibrous cap thickness (FCT) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: μm.	3 months
OCT-measured maximum lipid arc change at 3 months post-procedure	Change in maximum lipid arc measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: degrees.	3 months
OCT assessment of macrophage infiltration change at 3 months post-procedure	Change in macrophage infiltration presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.	3 months
OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure	Change in number of thin-cap fibroatheroma (TCFA) lesions measured by optical coherence tomography from baseline to 3 months post-procedure. TCFA defined as lipid-rich plaque with fibrous cap thickness <65μm. Unit: count.	3 months
OCT-measured lipid pool length change at 3 months post-procedure	Change in lipid pool length measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.	3 months
OCT assessment of microchannel change at 3 months post-procedure	Change in microchannel presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.	3 months
OCT-measured minimum lumen diameter change at 3 months post-procedure	Change in minimum lumen diameter measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm.	3 months
CCTA-measured perivascular fat attenuation index change at 6 months	Change in perivascular fat attenuation index (FAI) measured by coronary computed tomography angiography from baseline to 6 months post-procedure. FAI is defined as the mean CT attenuation value of perivascular adipose tissue surrounding the coronary artery. Unit: Hounsfield Units (HU).	6 months
CCTA-measured low-attenuation plaque volume change at 6 months post-procedure	Change in low-attenuation plaque volume measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Low-attenuation plaque is defined as plaque with CT value <30 HU. Unit: mm³.	6 months
CCTA-measured plaque burden change at 6 months post-procedure	Change in plaque burden measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Plaque burden is calculated as plaque volume divided by total vessel volume multiplied by 100%. Unit: percentage (%).	6 months
Incidence of target lesion failure (TLF) at 6 months post-procedure	Target lesion failure (TLF) was defined as a composite endpoint consisting of cardiovascular death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization.	6 months
Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure	Patient-oriented composite endpoint (PoCE) was defined as a composite of all-cause death, any stroke, any myocardial infarction, and any revascularization.	6 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Jie Zhao, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: RWT-P/S-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No