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Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Orsiro stent
Xience stent
Any drug-eluting stent
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug-eluting stents, Coronary bifurcation lesions, Double-kissing crush technique, Optical coherence tomography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
  2. Patients who are suitable for PCI with DES implantation and provide written informed consent.
  3. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
  4. Target vessels suitable for OCT examination.
  5. Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.

Exclusion Criteria:

  1. Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
  2. Estimated glomerular filtration rate < 45 ml/min/1.73 m2
  3. Liver cirrhosis
  4. Life expectancy < 1 year
  5. Planned surgery within 3 months
  6. Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
  7. Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction

Sites / Locations

  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Orsiro

Xience

Single stent

Arm Description

Two-stent DK-crush technique with Orsiro

Two-stent DK-crush technique with Xience

Provisional one-stent strategy with any drug-eluting stent

Outcomes

Primary Outcome Measures

Percentage of stent strut coverage at bifurcation segments

Secondary Outcome Measures

Neointimal thickness (μm) at bifurcation segments
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
Percentage of acquired malapposed struts at bifurcation segments
Percentage of stent strut coverage at bifurcation segments
Neointimal thickness (μm) at bifurcation segments
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
Percentage of acquired malapposed struts at bifurcation segments
In-stent late-lumen loss by quantitative coronary analysis
In-segment late lumen loss by quantitative coronary analysis
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Target Lesion Failure (TLF)
Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR
Major Cardiac Adverse Events (MACE)
Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Instent late-lumen loss by quantitative coronary analysis
In-segment late lumen loss by quantitative coronary analysis
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Target Lesion Failure (TLF)
Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR
Major Cardiac Adverse Events (MACE)
Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Stent thrombosis
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis
Stent thrombosis
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis
Stent thrombosis
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

Full Information

First Posted
January 4, 2022
Last Updated
January 16, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05200637
Brief Title
Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions
Official Title
A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.
Detailed Description
Patients with true coronary bifurcation lesions (Medina [1, 1, 1] or [0, 1, 1]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug-eluting stents, Coronary bifurcation lesions, Double-kissing crush technique, Optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with true coronary bifurcation lesions will be randomized to undergo two-stent DK-crush technique with Orsiro or Xience. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orsiro
Arm Type
Active Comparator
Arm Description
Two-stent DK-crush technique with Orsiro
Arm Title
Xience
Arm Type
Active Comparator
Arm Description
Two-stent DK-crush technique with Xience
Arm Title
Single stent
Arm Type
Other
Arm Description
Provisional one-stent strategy with any drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Orsiro stent
Intervention Description
Orsiro stent
Intervention Type
Device
Intervention Name(s)
Xience stent
Intervention Description
Xience stent
Intervention Type
Device
Intervention Name(s)
Any drug-eluting stent
Intervention Description
Any drug-eluting stent
Primary Outcome Measure Information:
Title
Percentage of stent strut coverage at bifurcation segments
Time Frame
3 months post-procedure
Secondary Outcome Measure Information:
Title
Neointimal thickness (μm) at bifurcation segments
Time Frame
3 months post-procedure
Title
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
Time Frame
3 months post-procedure
Title
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
Time Frame
3 months post-procedure
Title
Percentage of acquired malapposed struts at bifurcation segments
Time Frame
3 months post-procedure
Title
Percentage of stent strut coverage at bifurcation segments
Time Frame
12 months post-procedure
Title
Neointimal thickness (μm) at bifurcation segments
Time Frame
12 months post-procedure
Title
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
Time Frame
12 months post-procedure
Title
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
Time Frame
12 months post-procedure
Title
Percentage of acquired malapposed struts at bifurcation segments
Time Frame
12 months post-procedure
Title
In-stent late-lumen loss by quantitative coronary analysis
Time Frame
3 months post-procedure
Title
In-segment late lumen loss by quantitative coronary analysis
Time Frame
3 months post-procedure
Title
Target Lesion Revascularization (TLR)
Time Frame
3 months post-procedure
Title
Target Vessel Revascularization (TVR)
Time Frame
3 months post-procedure
Title
Target Lesion Failure (TLF)
Description
Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR
Time Frame
3 months post-procedure
Title
Major Cardiac Adverse Events (MACE)
Description
Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Time Frame
3 months post-procedure
Title
Instent late-lumen loss by quantitative coronary analysis
Time Frame
12 months post-procedure
Title
In-segment late lumen loss by quantitative coronary analysis
Time Frame
12 months post-procedure
Title
Target Lesion Revascularization (TLR)
Time Frame
12 months post-procedure
Title
Target Vessel Revascularization (TVR)
Time Frame
12 months post-procedure
Title
Target Lesion Failure (TLF)
Description
Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR
Time Frame
12 months post-procedure
Title
Major Cardiac Adverse Events (MACE)
Description
Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Time Frame
12 months post-procedure
Title
Stent thrombosis
Description
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis
Time Frame
1 months post-procedure
Title
Stent thrombosis
Description
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis
Time Frame
3 months post-procedure
Title
Stent thrombosis
Description
Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis
Time Frame
12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are at least 20 years old and present with acute or chronic coronary syndrome. Patients who are suitable for PCI with DES implantation and provide written informed consent. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique. Target vessels suitable for OCT examination. Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test. Exclusion Criteria: Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT) Estimated glomerular filtration rate < 45 ml/min/1.73 m2 Liver cirrhosis Life expectancy < 1 year Planned surgery within 3 months Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Chang Tung, MD
Phone
886-3-3281200
Ext
8162
Email
n12374@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Jen Chang, MD
Phone
886-3-3281200
Ext
8162
Email
chijenformosa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Chang Tung, MD
Organizational Affiliation
Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi-Jen Chang, MD
Organizational Affiliation
Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chia-Pin Lin, MD
Organizational Affiliation
Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

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