Evaluating the effectiveness of BioFreedom stents in real-world practice

Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

This study is testing how well the BioFreedom stent works in everyday patients compared to other stents to see if it helps with heart artery problems.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 17 sites (Anyang and 16 other locations)
• Trial ID: NCT03190057 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of the BIOFREEDOM™ FAMILY stent in everyday clinical settings, comparing its performance to other drug-eluting stents. Participants will include patients who have received a BioFreedom stent, and the study will gather data on outcomes related to coronary stenosis. The study will involve multiple hospitals in South Korea, focusing on real-world applications rather than controlled environments. Written consent will be required from all participants.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 19 and older who have received a BIOFREEDOM™ FAMILY stent.

Not a fit: Patients who are undergoing simultaneous intervention with other drug-eluting stents or have a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of BioFreedom stents, potentially improving treatment options for patients with coronary artery disease.

How similar studies have performed: Other studies evaluating drug-eluting stents have shown promising results, indicating that this approach is supported by previous research.

Eligibility criteria

Inclusion Criteria:

* Age 19 and more
* Patient with BIOFREEDOM™ FAMILY stent
* Written consent

Exclusion Criteria:

* Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
* Life-expectancy less than 1 year
* Cardiac shock

Where this trial is running

Anyang and 16 other locations

• Hallym University Sacred Heart Hospital — Anyang, Korea, Republic of (Recruiting)
• Soonchunhyang University Hospital, Cheonan — Cheonan, Korea, Republic of (Terminated)
• Gangwon National Univ. Hospital — Chuncheon, Korea, Republic of (Withdrawn)
• Daegu Catholic University Medical Center — Daegu, Korea, Republic of (Withdrawn)
• Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (Withdrawn)
• Chungnam National University Hospital — Daejeon, Korea, Republic of (Withdrawn)
• The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, Korea, Republic of (Terminated)
• Chonnam National University Hospital — Gwangju, Korea, Republic of (Recruiting)
• Inje University Ilsan Paik Hospital — Ilsan, Korea, Republic of (Recruiting)
• Gachon University Gil Hospital — Incheon, Korea, Republic of (Recruiting)
• Inje University Pusan Paik Hospital — Pusan, Korea, Republic of (Terminated)
• Bundang CHA Hospital — Seongnam, Korea, Republic of (Withdrawn)
• Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
• Eulji General Hospital — Seoul, Korea, Republic of (Terminated)
• Korea University Guro Hospital — Seoul, Korea, Republic of (Withdrawn)
• The Catholic Univ. of Korea Seoul St. Mary's hospital — Seoul, Korea, Republic of (Withdrawn)
• Pusan National University Yangsan Hospital — Yangsan, Korea, Republic of (Withdrawn)

Study contacts

• Study coordinator: Duk-woo Park, MD

Conditions Coronary Stenosis; BioFreedom; Drug Eluting Stent; Coronary Artery Disease