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NCT Number: NCT06544681

Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning

This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.

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Key information

About this study

In this study, we planned to retrospectively collect 2,000 subjects who underwent optical coherence tomography-guided percutaneous coronary stent implantation with an optical coherence tomography system constructed by a deep learning algorithm from 3 centers to assess stent apposition for coronary stent implantation, and to classify subjects into a group with poor stent apposition (axial distance >400 μm or length >1 mm) and a group with good stent apposition. All subjects were followed up within 12 months after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥20 years old;
  • Angiography was performed, and OCT imaging of criminal blood vessels was performed before intervention;
  • Type of coronary heart disease: Unstable angina pectoris (UA), ST elevation myocardial infarction (STEMI) And non-ST elevation myocardial infarction (NSTEMI);

Exclusion criteria

  • Lack of medical records;
  • Failure to complete follow-up;
  • Previous coronary artery bypass grafting;
  • Severe liver or kidney insufficiency;
  • Infectious diseases, malignancies and bleeding diseases;
  • OCT image quality was caused by large thrombus volume or residual blood in lumen and percutaneous coronary angiography Poor and further excluded.

Treatment and study plan

Coronary stenting with planned drug eluting stent (DES).

Procedure

Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.

Primary outcomes

  1. MACE

    Time frame: Post-procedure within 1 year

    Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Liu, M.D

CONTACT

[email protected]

+86 18653773715

Xiang Ma, Ph.D

CONTACT

[email protected]

+86 13669939349

Sponsors and collaborators

Lead sponsor

Xiang Ma

Other

Collaborators

  • Shihezi University

Registry information

Official study title

Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by Optical Coherence Tomography Based on Multimodal Deep Learning

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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