Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChina National Center for Cardiovascular Diseases

About this trial

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 criteria

Qualifiers

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%);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sirolimus-coated DCB
  • Paclitaxel-coated DCB

Treatment groups

60 Participants
are divided into 2 treatment groups