OCT in Borderline Coronary Artery Lesions

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: OCT


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT guided PCI<br> | Diagnostic Test: OCT<br>* OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions<br>|
| Experimental: OCT guided medicine<br> | Diagnostic Test: OCT<br>* OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions<br>|
| No Intervention: SPECT guided PCI<br> | |
| No Intervention: SPECT guided medicine<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACEs | The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis. | 12 months | 
| TLR | The incidence of target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization | The incidence of rehospitalization due to cardiac events | 12 months | 
| Recurrent angina | The incidence of recurrent angina | 12 months |