A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02513810
• Other study ID #: 1-2015-0040
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2015
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3020
• Est. completion date: September 2020
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients = 19 years old

• Patients with ischemic heart disease who are considered for coronary revascularization with PCI

• Significant coronary de novo lesion

Exclusion Criteria:

• Acute myocardial infarction

• Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion

• Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions

• Cardiogenic shock or experience of cardiopulmonary resuscitation

• Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media

• History of documented prior cerebrovascular attack within 6 months

• Treated with any stent within 3 months

• Reference vessel diameter <2.25 mm or >4.0 mm

• Pregnant women or women with potential childbearing

• Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

• Inability to understand or read the informed content

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• BioFreedom with 1 month DAPT
The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month.
• BioMatrix or Ultimaster with 6 to 12 months DAPT
The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiovascular events	events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident	1 year