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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05200637
• Other study ID #: 202101599A3
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

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