OCT in Borderline Coronary Artery Lesions

Not Applicable

Completed

• Conditions: Percutaneous Coronary Intervention (PCI); Optical Coherence Tomography (OCT); Single-Photon Emission Computed Tomography (SPECT); Coronary Angiography (CAG); Borderline Coronary Artery Lesions
• Interventions: Diagnostic Test: OCT

• Registration Number: NCT03229993
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-23
• Study First Posted: 2017-07-26
• Study Start: 2017-12-31
• Primary Completion: 2018-01-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT guided medicine	OCT	-
OCT guided PCI	OCT	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rehospitalization	12 months	The incidence of rehospitalization due to cardiac events
Recurrent angina	12 months	The incidence of recurrent angina

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China