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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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 7, 2016
Last Updated
May 17, 2018
Sponsor
Yonsei University
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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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