Biofreedom Prospective Multicenter Observational Registry

NCT03045848 | Terminated DMC

• 1 other identifier: Biofreedom V2.2
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Coronary Artery Disease Aggravated; Myocardial Ischemia; Myocardial Infarction

Keywords

Observational registry; All-comers open label registry; Drug coated stent; Multicenter; Stenting; Coronary Artery Disease; Coronary revascularization; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patient-oriented composite end point

  12 months

• Cardiac death

  12 months

• Non-cardiac death

  12 months

• Any myocardial infarction

  12 months

• Any myocardial infarction not clearly attributable to a non-target vessel

  12 months

Study Arms (1)

Biofreedom drug-coated stent

Subject implanted Biofreedom DCS for coronary artery disease

Device: Biofreedom drug-coated stent

Interventions

Biofreedom drug-coated stent DEVICE

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.

Biofreedom drug-coated stent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)

You may qualify if:

• Subject with ≥ 19 years
• Subject implanted with Biofreedom DCS within 1 month
• Subject who decided to participation and signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Cordis US Corp.: collaborator

Study Sites (16)

Dankook University Hospital

Cheonan, Chungcheongnam-do, 31116, South Korea

Location

Kangwon National University School of Medicine

Chuncheon, Gangwon-do, 200-722, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, 21565, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13495, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Yeungnam University Medical Center

Daegu, Gyeongsangbuk-do, 42415, South Korea

Location

Daegu Catholic University Medical Center

Daegu, Gyeongsangbuk-do, 42472, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, Gyeongsangnam-do, 50612, South Korea

Location

Eulji General Hospital

Seoul, 01830, South Korea

Location

KyungHee University at Gangdong

Seoul, 05278, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Veterans Health Service Medical Center

Seoul, 134-791, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia; Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Junghan Yoon, MD, PhD

  Yonsei University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 8, 2017
• Study Start: July 5, 2018
• Primary Completion: June 30, 2020
• Study Completion: November 10, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

KR (16)