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Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents

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Yonsei University

Status

Not yet enrolling

Conditions

Coronary Artery Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03873012
4-2018-1167

Details and patient eligibility

About

This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.

Full description

This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.

Enrollment

894 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. patients who were enrolled in the previous DETECT-OCT study
    1. Patients who agreed with informed consents

Exclusion criteria

    1. Patients who disagreed with informed consents

Trial design

894 participants in 2 patient groups

OCT-guided group
Description:
OCT-guided PCI with EES or BES
Angiography-guidance group
Description:
Angio-guided PCI with EES or BES

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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