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Biofreedom Prospective Multicenter Observational Registry

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ClinicalTrials.gov Identifier: NCT03045848
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Cordis Corporation
Information provided by (Responsible Party):
Junghan Yoon, Wonju Severance Christian Hospital

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Aggravated Myocardial Ischemia Myocardial Infarction Device: Biofreedom drug-coated stent

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Biofreedom drug-coated stent
Subject implanted Biofreedom DCS for coronary artery disease
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient-oriented composite end point [ Time Frame: 12 months ]
    Composite of any death, any myocardial infarction, and any revascularization

  2. Cardiac death [ Time Frame: 12 months ]
  3. Non-cardiac death [ Time Frame: 12 months ]
  4. Any myocardial infarction [ Time Frame: 12 months ]
  5. Any myocardial infarction not clearly attributable to a non-target vessel [ Time Frame: 12 months ]
  6. Any revascularization [ Time Frame: 12 months ]
  7. Clinically indicated target-lesion revascularization [ Time Frame: 12 months ]
  8. Clinically indicated target-vessel revascularization [ Time Frame: 12 months ]
  9. ARC defined stent thrombosis [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045848


Contacts
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Contact: Junghan Yoon, MD, PhD +82-33-741-1219 jyoon@yonsei.ac.kr
Contact: Jun-Won Lee, MD +82-33-741-1219 ljwcardio@yonsei.ac.kr

Locations
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Korea, Republic of
Dankook University Hospital Recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 31116
Contact: Tae Soo Kang, MD    +82-41-550-3914    neosoo70@dankook.ac.kr   
Kangwon National University School of Medicine Recruiting
Chuncheon, Gangwon-do, Korea, Republic of, 200-722
Contact: Byung-Ryul Cho, MD    +82-33-258-9226    heartcho@kangwon.ac.kr   
Principal Investigator: Byung-Ryul Cho, MD         
Wonju Severance Christian Hospital Recruiting
Wonju, Gangwon-do, Korea, Republic of, 26426
Contact: Junghan Yoon, MD, PhD    +82-33-741-1219    jyoon@yonsei.ac.kr   
Contact: Jun-Won Lee, MD    +82-33-741-1219    ljwcardio@yonsei.ac.kr   
Principal Investigator: Jun-Won Lee, MD         
Sub-Investigator: Seung-Hwan Lee, MD, PhD         
Sub-Investigator: Byung-Su Yoo, MD, PhD         
Sub-Investigator: Jang-Young Kim, MD, PhD         
Sub-Investigator: Min-Soo Ahn, MD         
Sub-Investigator: Sung-Gyun Ahn, MD         
Sub-Investigator: Junghan Yoon, MD, PhD         
Sub-Investigator: Young-Jin Youn, MD         
Sub-Investigator: Jung-Woo Son, MD         
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Nae-Hui Lee, MD    +82-32-621-5437    naeheelee@naver.com   
Principal Investigator: Nae-Hui Lee, MD         
Gachon University Gil Medical Center Recruiting
Incheon, Gyeonggi-do, Korea, Republic of, 21565
Contact: Tae Hoon Ahn, MD    +82-32-460-8385    encore@gilhospital.com   
Principal Investigator: Tae Hoon Ahn, MD         
CHA Bundang Medical Center Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13495
Contact: In Jai Kim, MD    +82-31-780-5852    swlim@cha.ac.kr   
Principal Investigator: In Jai Kim, MD         
Ajou University Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Contact: So-Yeon Choi, MD    +82-31-219-5712    sychoimd@outlook.com   
Principal Investigator: So-Yeon Choi, MD         
Yeungnam University Medical Center Recruiting
Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
Contact: Joong-Hee Lee, MD    +82-53-620-3313    seranflute@gmail.com   
Principal Investigator: Joong-Hee Lee, MD         
Daegu Catholic University Medical Center Recruiting
Daegu, Gyeongsangbuk-do, Korea, Republic of, 42472
Contact: Jin-Bae Lee, MD    +82-53-650-4389    jblee@cu.ac.kr   
Principal Investigator: Jin-Bae Lee, MD         
Pusan National University Yangsan Hospital Recruiting
Busan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Kook-Jin Chun, MD    +82-55-360-1454    ptca82@gmail.com   
Principal Investigator: Kook-Jin Chun, MD         
Eulji General Hospital Recruiting
Seoul, Korea, Republic of, 01830
Contact: Jae Woong Choi, MD    +82-2-970-8203    cjw1108@eulji.ac.kr   
Principal Investigator: Jae Woon Choi, MD         
KyungHee University at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact: Jin-Man Cho, MD    +82-2-440-6107    cardiocho@gmail.com   
Principal Investigator: Jin-Man Cho, MD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Contact: Byoung Kwon Lee, MD    +82-2-2019-3311    cardiobk@yuhs.ac   
Principal Investigator: Byoung Kwon Lee, MD         
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Contact: Sang-Wook Kim, MD    +82-2-6299-1395    swivus@gmail.com   
Principal Investigator: Sang-Wook Kim, MD         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Contact: Sang-Hyun Kim, MD    +82-2-870-3864    shkimmd@snu.ac.kr   
Principal Investigator: Sang Hyun Kim, MD         
Veterans Health Service Medical Center Recruiting
Seoul, Korea, Republic of, 134-791
Contact: Chang Hoon Lee, MD    +82-2-2225-4141    zekilee@hanmail.net   
Principal Investigator: Chang Hoon Lee, MD         
Sponsors and Collaborators
Wonju Severance Christian Hospital
Cordis Corporation
Investigators
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Study Director: Junghan Yoon, MD, PhD Yonsei University

Additional Information:

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Responsible Party: Junghan Yoon, Professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT03045848    
Other Study ID Numbers: Biofreedom V2.2
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Junghan Yoon, Wonju Severance Christian Hospital:
Observational registry
All-comers open label registry
Drug coated stent
Multicenter
Stenting
Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases