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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Orsiro stent; Device: Xience stent; Device: Any drug-eluting stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying-Chang Tung, MD; Phone Number: 8162 886-3-3281200; Email: n12374@cgmh.org.tw
• Study Contact Backup: Name: Chi-Jen Chang, MD; Phone Number: 8162 886-3-3281200; Email: chijenformosa@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orsiro; Two-stent DK-crush technique with Orsiro	Device: Orsiro stent; Orsiro stent
Active Comparator: Xience; Two-stent DK-crush technique with Xience	Device: Xience stent; Xience stent
Other: Single stent; Provisional one-stent strategy with any drug-eluting stent	Device: Any drug-eluting stent; Any drug-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of stent strut coverage at bifurcation segments	3 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal thickness (μm) at bifurcation segments		3 months post-procedure
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments		3 months post-procedure
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments		3 months post-procedure
Percentage of acquired malapposed struts at bifurcation segments		3 months post-procedure
Percentage of stent strut coverage at bifurcation segments		12 months post-procedure
Neointimal thickness (μm) at bifurcation segments		12 months post-procedure
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments		12 months post-procedure
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments		12 months post-procedure
Percentage of acquired malapposed struts at bifurcation segments		12 months post-procedure
In-stent late-lumen loss by quantitative coronary analysis		3 months post-procedure
In-segment late lumen loss by quantitative coronary analysis		3 months post-procedure
Target Lesion Revascularization (TLR)		3 months post-procedure
Target Vessel Revascularization (TVR)		3 months post-procedure
Target Lesion Failure (TLF)	Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR	3 months post-procedure
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)	3 months post-procedure
Instent late-lumen loss by quantitative coronary analysis		12 months post-procedure
In-segment late lumen loss by quantitative coronary analysis		12 months post-procedure
Target Lesion Revascularization (TLR)		12 months post-procedure
Target Vessel Revascularization (TVR)		12 months post-procedure
Target Lesion Failure (TLF)	Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR	12 months post-procedure
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)	12 months post-procedure
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	1 months post-procedure
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	3 months post-procedure
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	12 months post-procedure

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ying-Chang Tung, MD, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; Study Chair: Chi-Jen Chang, MD, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; Study Director: Chia-Pin Lin, MD, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Coronary bifurcation lesions; Drug-eluting stents; Double-kissing crush technique
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 202101599A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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