OCT in Borderline Coronary Artery Lesions

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03229993

Enrollment

220

Registered

2017-07-26

Start date

2017-12-31

Completion date

2019-12-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DIAGNOSTIC_TESTOCT

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Rehospitalization	12 months	The incidence of rehospitalization due to cardiac events
Recurrent angina	12 months	The incidence of recurrent angina

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026