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

NCT ID: NCT03873012

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 894 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

OCT-guided group

OCT-guided PCI with EES or BES

No interventions assigned to this group

Angiography-guidance group

Angio-guided PCI with EES or BES

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1. Patients who disagreed with informed consents

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.

Reference Type: BACKGROUND

PMID: 30562088 (View on PubMed)

Other Identifiers

4-2018-1167

Identifier Type: -

Identifier Source: org_study_id