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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

Tracking Information
First Submitted Date January 29, 2017
First Posted Date February 8, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date July 5, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2017)
  • Patient-oriented composite end point [ Time Frame: 12 months ]
    Composite of any death, any myocardial infarction, and any revascularization
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biofreedom Prospective Multicenter Observational Registry
Official Title Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Biofreedom Stent in Patients With Coronary Artery Disease (Biofreedom Registry)
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All-comers patient population with all subjects requiring coronary revascularization with a drug-coated stent (DCS)
Condition
  • Coronary Artery Disease Aggravated
  • Myocardial Ischemia
  • Myocardial Infarction
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.
Study Groups/Cohorts Biofreedom drug-coated stent
Subject implanted Biofreedom DCS for coronary artery disease
Intervention: Device: Biofreedom drug-coated stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019)
200
Original Estimated Enrollment
 (submitted: February 3, 2017)
2000
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03045848
Other Study ID Numbers Biofreedom V2.2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Junghan Yoon, Wonju Severance Christian Hospital
Study Sponsor Wonju Severance Christian Hospital
Collaborators Cordis Corporation
Investigators
Study Director: Junghan Yoon, MD, PhD Yonsei University
PRS Account Wonju Severance Christian Hospital
Verification Date July 2019