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Not yet recruiting NCT07514988

Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

No phase Interventional Acute Coronary Syndromes (ACS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sirolimus-coated DCB, Paclitaxel-coated DCB.
Who it may be relevant to
Registry conditions: Acute Coronary Syndromes (ACS). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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).

Interventions

  • Device Sirolimus-coated DCB
    Treatment of sirolimus-coated DCB
  • Device Paclitaxel-coated DCB
    Treatment of paclitaxel-coated DCB

Primary outcome measures

  • Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure [Time frame: 3 months]
Secondary outcome measures (12)
  • OCT-measured minimum lumen area change at 3 months post-procedure [Time frame: 3 months]
  • OCT-measured fibrous cap thickness change at 3 months post-procedure [Time frame: 3 months]
  • OCT-measured maximum lipid arc change at 3 months post-procedure [Time frame: 3 months]
  • OCT assessment of macrophage infiltration change at 3 months post-procedure [Time frame: 3 months]
  • OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure [Time frame: 3 months]
  • OCT-measured lipid pool length change at 3 months post-procedure [Time frame: 3 months]
  • OCT assessment of microchannel change at 3 months post-procedure [Time frame: 3 months]
  • OCT-measured minimum lumen diameter change at 3 months post-procedure [Time frame: 3 months]
  • CCTA-measured perivascular fat attenuation index change at 6 months [Time frame: 6 months]
  • CCTA-measured low-attenuation plaque volume change at 6 months post-procedure [Time frame: 6 months]
  • CCTA-measured plaque burden change at 6 months post-procedure [Time frame: 6 months]
  • Incidence of target lesion failure (TLF) at 6 months post-procedure [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

  • Age between 18 and 80 years old, both genders eligible;
  • 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;
  • Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
  • 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%);
  • 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai hospital, CAMS&PUMC — Beijing

Identifiers

NCT: NCT07514988 · RWT-P/S-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗