Biofreedom Prospective Multicenter Observational Registry

Myocardial Infarction Clinical Trial

Official title:

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03045848
• Other study ID #: Biofreedom V2.2
• Status: Terminated
• Start date: July 5, 2018
• Est. completion date: November 10, 2020

Study information

• Verified date: May 2021
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent (Biofreedom, Biosensors International Technologies, Singapore) in patients with high bleeding risk. But, there are limited clinical evidences for extending these findings to generalized patients who are eligible to PCI. Therefore, the purpose of this registry is to evaluate the safety and efficacy of Biofreedom stent in patients with coronary artery disease.

Description:

Percutaneous coronary intervention (PCI) and related interventional cardiology field are rapidly growing in current era. First generation drug eluting stent (DES) needed long-term dual antiplatelet therapy (DAPT) for preventing future stent thrombosis. But, second generation DES showed better clinical outcomes in terms of target lesion revascularization and stent thrombosis. Later, polymer technology that was used to release drugs gradually improved. BASKET-PROVE II trial compared biodegradable polymer (BP) DES (Nobori, Terumo) with durable polymer DES (Xience Prime, Abbott Vascular) and bare metal stent (ProKinetik, Biotronik) for the safety and efficacy in 2-year follow-up. BP-DES showed 7.6% of event rates in composite endpoint including cardiac death, myocardial infarction (MI), clinically indicated target-vessel revascularization (TVR) which was non-inferior to DP-DES(6.8%) and superior to bare metal stent (12.7%). There were no statistical differences for the event rates of stent thrombosis, MI and cardiac death among three groups in 1-year follow-up. Biodegradable polymer has begun to emerge and suggested the possibility of shortening the duration of DAPT. LEEDERS-FREE trial was designed to confirm the safety and efficacy of polymer-free drug-coated stent (Biofreedom, Biosensors International Technologies, Singapore) compared to bare metal stent (Gazelle stent, Biosensors International Technologies, Singapore) in patients with high bleeding risk. During 390 days, drug coated stent showed significant superiority to bare metal stent for the safety composite endpoint (cardiac death, MI or stent thrombosis) (9.4% vs. 12.9%, P=0.0005). Clinically-driven target-lesion revascularization also showed significant differences between drug-coated stent (5.1%) and bare metal stent (9.8%) (P<0.001). This results provided new therapeutic options that DAPT duration could be shortened to 1 month in patients with high bleeding risk. The rate of cardiovascular events was relatively higher than second generation DES. However, this result should be carefully interpreted because the main purpose of LEADERS-FREE trial is to enroll high bleeding risk patients who are generally excluded in second generation DES studies. Additional studies are needed because there are limited clinical evidences for extending these findings of LEADERS-FREE trial to generalized patients who are eligible to PCI.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. completion date: November 10, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Subject with = 19 years

• Subject implanted with Biofreedom DCS within 1 month

• Subject who decided to participation and signed informed consent

Exclusion Criteria:

• Known intolerance to heparin, aspirin, clopidogrel, biolimus, cobalt chromium or contrast media (Subject with hypersensitivity to contrast media controlled by steroid and pheniramine can be included this study, but subject with anaphylaxis to contrast media will be excluded).

• Pregnancy

• Woman who have a plan of pregnancy during study period

• Subject with life expectancy less than 12 months

• Subject with cardiogenic shock

• Subject treated with other drug-eluting stent (DES), bioresorbable vascular scaffold (BVS) or bare metal stent (BMS)

• Subject participating in other randomized controlled study with DES, BVS or BMS

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Aggravated
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Biofreedom drug-coated stent
BioFreedom (Biosensors International Technologies, Singapore) is the only polymer- and carrier-free drug coated stent with Biolimus A9 in a selectively micro-structured abluminal surface. It is a stainless steel bare metal surface with 120 micron thick corrugated ring strut.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Busan	Gyeongsangnam-do
Korea, Republic of	Dankook University Hospital	Cheonan	Chungcheongnam-do
Korea, Republic of	Kangwon National University School of Medicine	Chuncheon	Gangwon-do
Korea, Republic of	Daegu Catholic University Medical Center	Daegu	Gyeongsangbuk-do
Korea, Republic of	Yeungnam University Medical Center	Daegu	Gyeongsangbuk-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	KyungHee University at Gangdong	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Veterans Health Service Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Cordis Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-oriented composite end point (TLF)	Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization	12 months
Secondary	Patient-oriented composite end point	Composite of any death, any myocardial infarction, and any revascularization	12 months
Secondary	Cardiac death		12 months
Secondary	Non-cardiac death		12 months
Secondary	Any myocardial infarction		12 months
Secondary	Any myocardial infarction not clearly attributable to a non-target vessel		12 months
Secondary	Any revascularization		12 months
Secondary	Clinically indicated target-lesion revascularization		12 months
Secondary	Clinically indicated target-vessel revascularization		12 months
Secondary	ARC defined stent thrombosis		12 months