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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05200637
Other study ID # 202101599A3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2022
Source Chang Gung Memorial Hospital
Contact Ying-Chang Tung, MD
Phone 886-3-3281200
Email n12374@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Orsiro stent
Orsiro stent
Xience stent
Xience stent
Any drug-eluting stent
Any drug-eluting stent

Locations

Country Name City State
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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