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Clinical Trials in China / NCT07514988
Starting soon Not applicable

Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

NCT07514988 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Not applicable
Started
2026-05-01
Last updated
2026-04-07

Condition(s) studied

Acute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Sirolimus-coated DCBPaclitaxel-coated DCB

Sirolimus-coated DCB: Treatment of sirolimus-coated DCB

Paclitaxel-coated DCB: Treatment of paclitaxel-coated DCB

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fuwai hospital, CAMS&PUMC Beijing Beijing Municipality

More China National Center for Cardiovascular Diseases trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07514988 on ClinicalTrials.gov ↗ ← All trials in China