Trials
Search / Trial NCT06416813

Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques

Launched by YONG HE · May 10, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years Diagnosis of ACS with the intention to undergo ICA There exists a nonculprit lesion characterized by a single diameter stenosis greater than 50% in the major coronary artery segments (with diameters ranging from 2.75 to 4 mm).
  • QFR value \> 0.8 The OCT examination suggests vulnerable plaques with a fibrous cap thickness of \< 65 µm, along with at least two of the other three OCT criteria Minimum lumen area \<3.5 mm² Lipid core angle \>180° Presence of macrophages lesion length ≤30 mm Provide informed consent Life expectancy greater than 1 year
  • Exclusion Criteria:
  • Patients with three or more target lesions or with two target lesions in the same coronary artery left main stem lesions Ostial lesions Thrombotic lesions Severe calcification or angulated lesions True bifurcation lesions requiring stent implantation Advanced heart failure (NYHA III-IV) Ischemic stroke in the past 6 months or any history of cerebral hemorrhage at any time Severe valve disease or valve disease that may require surgical or percutaneous valve replacement Coronary artery anatomy obstructs the complete imaging of the segment of interest (including at least 5 mm beyond the narrow ends).
  • Diffuse coronary artery disease or the presence of ≥1 untreated nonculprit lesion (nonculprit blood flow-restricting lesion planned for staged PCI).
  • History of myocardial infarction, CABG, or PCI Coronary artery anatomy not suitable for PCI The potential comorbidity that may impact the completion of the trial process. The planned major surgery requires discontinuation of DAPT. History of PCSK9 inhibitor (such as evolocumab or alirocumab) use within 90 days prior to the first study visit.
  • Exposed to Inclisiran or any other non-PCSK9 monoclonal antibody targeted treatment within the 2 years preceding the initial study visit, whether as an investigational drug or a marketed medication.
  • History of allergy to the investigational drug, its excipients, or other siRNA drugs Females of childbearing potential, defined as all female subjects physiologically capable of becoming pregnant, unless they are using effective contraception during the administration of the investigational drug

About Yong He

Yong He is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing novel therapeutics and enhancing patient outcomes, Yong He collaborates with leading research institutions and healthcare professionals to design and implement rigorous clinical trials. The organization prioritizes ethical standards, regulatory compliance, and patient safety, ensuring that all studies contribute to the scientific understanding of diseases and the efficacy of new treatments. Through its commitment to excellence and transparency, Yong He aims to facilitate breakthroughs that improve health and quality of life for diverse populations.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0