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

NCT03873012 | Not Yet Recruiting

• 1 other identifier: 4-2018-1167
• Study Type: observational
• Target: 894
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Dual antiplatelet therapy duration; Optical coherence tomography

Outcome Measures

Primary Outcomes (12)

• Overall survival

  Free from death

  At 5 years

• Overall survival

  Free from death

  At 10 years

• Cardiac death

  Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.

  At 5 years

• Cardiac death

  Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.

  At 10 years

• Myocardial infarction

  (Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)

  At 5 years

• Myocardial infarction

  (Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)

  At 10 years

• Target lesion revascularization

  Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.

  At 5 years

• Target lesion revascularization

  Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.

  At 10 years

• Target vessel revascularization

  Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.

  At 5 years

• Target vessel revascularization

  Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.

  At 10 years

• Stent thrombosis

  Based on the Academic Research Consortium (ARC) definition. 1. Definitive stent thrombosis 2. Probable stent thrombosis 3. Possible stent thrombosis

  At 5 years

• Stent thrombosis

  Based on the Academic Research Consortium (ARC) definition. 1. Definitive stent thrombosis 2. Probable stent thrombosis 3. Possible stent thrombosis

  At 10 years

Study Arms (2)

OCT-guided group

OCT-guided PCI with EES or BES

Angiography-guidance group

Angio-guided PCI with EES or BES

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who already enrolled in DETECT-OCT

You may qualify if:

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

You may not qualify if:

• \. Patients who disagreed with informed consents

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30562088 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: April 1, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

KR (1)