OCT in Borderline Coronary Artery Lesions

NCT ID: NCT03229993

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OCT guided PCI

Group Type EXPERIMENTAL

OCT

Intervention Type DIAGNOSTIC_TEST

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

OCT guided medicine

Group Type EXPERIMENTAL

OCT

Intervention Type DIAGNOSTIC_TEST

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

SPECT guided PCI

Group Type NO_INTERVENTION

No interventions assigned to this group

SPECT guided medicine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OCT-20170723

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.