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OpenTrials
Completed

NCT Number: NCT03229993

OCT in Borderline Coronary Artery Lesions

To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.

It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.

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Key information

Conditions

Optical Coherence Tomography (OCT) Borderline Coronary Artery Lesions Coronary Angiography (CAG) Percutaneous Coronary Intervention (PCI) Single-Photon Emission Computed Tomography (SPECT)

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.

Exclusion criteria

  • Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.

Treatment and study plan

OCT

Diagnostic Test

OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions

Primary outcomes

  1. MACEs

    Time frame: 12 months

    The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.

  2. TLR

    Time frame: 12 months

    The incidence of target lesion revascularization (TLR)

Secondary outcomes

  1. Rehospitalization

    Time frame: 12 months

    The incidence of rehospitalization due to cardiac events

  2. Recurrent angina

    Time frame: 12 months

    The incidence of recurrent angina

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 26, 2017
Registry last updated
Jul 17, 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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