OCT in Borderline Coronary Artery Lesions

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03229993

Collaborator

(none)

220

Enrollment

Location

Arms

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optical Coherence Tomography (OCT) Percutaneous Coronary Intervention (PCI) Single-Photon Emission Computed Tomography (SPECT) Coronary Angiography (CAG) Borderline Coronary Artery Lesions	Diagnostic Test: OCT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 31, 2017

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCT guided PCI	Diagnostic Test: OCT OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions
Experimental: OCT guided medicine	Diagnostic Test: OCT OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions
No Intervention: SPECT guided PCI
No Intervention: SPECT guided medicine

Outcome Measures

Primary Outcome Measures

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

Rehospitalization [12 months]
The incidence of rehospitalization due to cardiac events
Recurrent angina [12 months]
The incidence of recurrent angina

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT03229993

Other Study ID Numbers:

OCT-20170723

First Posted:

Jul 26, 2017

Last Update Posted:

Jul 17, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 17, 2020