Clinical trial NCT02622100: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Keywords: Bioresorbable Vascular Scaffold
Routine Clinical Practice
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
drug eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2015-12-04
Enrollment: 629
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Bioresorbable Vascular Scaffold

Brief summary: The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Intervention with Bioresorbable Vascular Scaffold
* Agreed with written informed consent form

Exclusion Criteria:

* Bypass graft surgery (CABG) recommended
* Lesion with previous bypass graft surgery (CABG)
* Severe calcification and/or severe tortuosity
* Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
* Life expectancy of 1year and under
* Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
* Cardiac shock

Primary outcomes:
measure: Composite event
timeFrame: 1 year
Secondary outcomes:
measure: all death
timeFrame: 5 years
measure: cardiac death
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: Composite event of death or myocardial infarction
timeFrame: 5 years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5 years
measure: Target Vessel revascularization
timeFrame: 5 years
measure: Target Lesion revascularization
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
measure: Procedural success
timeFrame: 3 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Jeonju
country: Korea, Republic of
facility: ChonBuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hosp
Study officials:
References: