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OpenTrials
Completed

NCT Number: NCT04444037

Impact of OCT Imaging on Decision Making During PCI in ACS Patients

Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

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Key information

Conditions

Acute Coronary Syndrome Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wakayama Medical University

Wakayama, 641-8509, Japan

About this study

OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion morphologies and larger extent of coronary atherosclerosis compared with stable coronary artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and which may improve acute results and late outcomes of PCI. Stent expansion immediately after PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical outcomes in many previous trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presented with acute coronary syndrome.
  • PCI was done to them with stent implantation.

Exclusion criteria

  • Multivessel PCI at the index procedure.
  • Patients with ACS due to graft failure post CABG.
  • Patients treated with no stent implantation.

Treatment and study plan

OCT-guided PCI

Device

using optical coherence tomography imaging to help PCI procedure

Primary outcomes

  1. Percent difference in lumen expansion in stent treated lesion

    Time frame: Immediately after the procedure

    Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.

Secondary outcomes

  1. Clinical outcomes at 1 year follow up

    Time frame: During 1 year following the index procedure

    Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Wakayama Medical University

Registry information

Official study title

Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Jun 24, 2020

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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