A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
PCI with Xience everolimus-eluting metallic stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring bioresorbable vascular scaffold, drug eluting stent, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Age 19-85 years
- Patients with ischemic heart disease requiring PCI
- Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
- Reference vessel diameter of 2.5 to 3.75 mm by operator assessment
Exclusion Criteria:
- Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
- Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Treated with any metallic stent or BVS within 3 months at other vessel
- Cardiogenic shock
- Left ventricular ejection fraction <40%
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
absorb arm
Xience arm
Arm Description
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
PCI with Xience everolimus-eluting metallic stent
Outcomes
Primary Outcome Measures
Incidence of composite of major adverse cardiovascular events
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02796157
Brief Title
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
bioresorbable vascular scaffold, drug eluting stent, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
950 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
absorb arm
Arm Type
Active Comparator
Arm Description
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Arm Title
Xience arm
Arm Type
Experimental
Arm Description
PCI with Xience everolimus-eluting metallic stent
Intervention Type
Device
Intervention Name(s)
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Intervention Description
Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.
Intervention Type
Device
Intervention Name(s)
PCI with Xience everolimus-eluting metallic stent
Intervention Description
Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.
Primary Outcome Measure Information:
Title
Incidence of composite of major adverse cardiovascular events
Description
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
Time Frame
1 year after PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 19-85 years
Patients with ischemic heart disease requiring PCI
Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
Reference vessel diameter of 2.5 to 3.75 mm by operator assessment
Exclusion Criteria:
Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
Contraindication or hypersensitivity to anti-platelet agents or contrast media
Treated with any metallic stent or BVS within 3 months at other vessel
Cardiogenic shock
Left ventricular ejection fraction <40%
Pregnant women or women with potential childbearing
Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Inability to understand or read the informed content
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MYEONG-KI HONG, MD
Phone
82-2-2228-8458
Email
MKHONG61@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32279841
Citation
Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.
Results Reference
derived
Learn more about this trial
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
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