Coronary Artery Disease AggravatedNCT03045848
Biofreedom Prospective Multicenter Observational Registry
An observational study of Coronary Artery Disease Aggravated and Myocardial Ischemia, run by Wonju Severance Christian Hospital at 16 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease Aggravated, Myocardial Ischemia, Myocardial Infarction
- What is being tested?
- Biofreedom drug-coated stent
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 5 Jul 2018to 10 Nov 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)
Who may be able to join
- Subject with ≥ 19 years
- Subject implanted with Biofreedom DCS within 1 month
- Subject who decided to participation and signed informed consent
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Dankook University Hospital
Cheonan, Chungcheongnam-do, 31116
Kangwon National University School of Medicine
Chuncheon, Gangwon-do, 200-722
Yeungnam University Medical Center
Daegu, Gyeongsangbuk-do, 42415
Daegu Catholic University Medical Center
Daegu, Gyeongsangbuk-do, 42472
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, 21565
Pusan National University Yangsan Hospital
Pusan, Gyeongsangnam-do, 50612
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13495
Eulji General Hospital
Seoul, 01830
KyungHee University at Gangdong
Seoul, 05278
Gangnam Severance Hospital
Seoul, 06273
Chung-Ang University Hospital
Seoul, 06973
Seoul National University Boramae Medical Center
Seoul, 07061
Veterans Health Service Medical Center
Seoul, 134-791
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)
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.
Read the detailed 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.
- Being tested
- Biofreedom drug-coated stent
- Keywords
- Observational registry, All-comers open label registry, Drug coated stent, Multicenter, Stenting, Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofreedom drug-coated stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofreedom drug-coated stent | Subject implanted Biofreedom DCS for coronary artery disease Receives: Device: Biofreedom drug-coated stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
Patient-oriented composite end point
Composite of any death, any myocardial infarction, and any revascularization
Measured: 12 months
Cardiac death
Measured: 12 months
Non-cardiac death
Measured: 12 months
Any myocardial infarction
Measured: 12 months
Any myocardial infarction not clearly attributable to a non-target vessel
Measured: 12 months
Any revascularization
Measured: 12 months
Clinically indicated target-lesion revascularization
Measured: 12 months
Clinically indicated target-vessel revascularization
Measured: 12 months
ARC defined stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start5 Jul 2018
- Primary completion30 Jun 2020
- Study completion10 Nov 2020
Why it stopped: Impossible device delivery because of sponsor change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease AggravatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cordis US Corp.
- Responsible party
- Principal investigator, Junghan Yoon, Wonju Severance Christian Hospital
- Investigators
- Junghan Yoon, MD, PhD, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045848
- Sponsor's protocol ID
- Biofreedom V2.2
- Status last verified
- May 2021
- First submitted
- 29 Jan 2017
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)
- ClinicalTrials.gov ID
- NCT03045848
- Acronym / sponsor ID
- Biofreedom V2.2
- Keywords
- Observational registry, All-comers open label registry, Drug coated stent, Multicenter, Stenting, Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Impossible device delivery because of sponsor change
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Cordis US Corp.
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofreedom drug-coated stent | – | Device: Biofreedom drug-coated stentSubject implanted Biofreedom DCS for coronary artery disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)
Key inclusion criteria (3 listed)
- Subject with ≥ 19 years
- Subject implanted with Biofreedom DCS within 1 month
- Subject who decided to participation and signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofreedom drug-coated stentBioFreedom (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. | Device | Biofreedom drug-coated stent |
Primary outcome
Device-oriented composite end point (TLF)
Time frame: 12 months
Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
9 secondary outcomes
Patient-oriented composite end point
Time frame: 12 months
Cardiac death
Time frame: 12 months
Non-cardiac death
Time frame: 12 months
Any myocardial infarction
Time frame: 12 months
Any myocardial infarction not clearly attributable to a non-target vessel
Time frame: 12 months
Any revascularization
Time frame: 12 months
Clinically indicated target-lesion revascularization
Time frame: 12 months
Clinically indicated target-vessel revascularization
Time frame: 12 months
ARC defined stent thrombosis
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Impossible device delivery because of sponsor change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junghan Yoon, MD, PhD study director
Yonsei University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease Aggravated and Myocardial Ischemia, run by Wonju Severance Christian Hospital at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impossible device delivery because of sponsor change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-oriented composite end point (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.