Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

N/ANot Yet RecruitingNCT07514988

China National Center for Cardiovascular Diseases60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Coronary Syndromes (ACS)

Interventions

Sirolimus-coated DCBDEVICE

Treatment of sirolimus-coated DCB

Paclitaxel-coated DCBDEVICE

Treatment of paclitaxel-coated DCB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fuwai hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 months

OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure

Central Contacts

Jie Zhao, MD, PhD

CONTACT

+8613911036089 fwzhaojie@126.com

Data from ClinicalTrials.gov

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