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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05200637
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-16
• Last Update Submitted: 2022-01-16
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Study Start: 2022-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of stent strut coverage at bifurcation segments	3 months post-procedure

Secondary Outcome Measures

Name	Time	Method
In-stent late-lumen loss by quantitative coronary analysis	3 months post-procedure
Target Lesion Revascularization (TLR)	12 months post-procedure
Target Vessel Revascularization (TVR)	12 months post-procedure
Stent thrombosis	12 months post-procedure	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
Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments	12 months post-procedure
Percentage of stent strut coverage at bifurcation segments	12 months post-procedure
Major Cardiac Adverse Events (MACE)	12 months post-procedure	Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Neointimal thickness (μm) at bifurcation segments	12 months post-procedure
In-segment late lumen loss by quantitative coronary analysis	12 months post-procedure
Target Lesion Failure (TLF)	12 months post-procedure	Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments	12 months post-procedure
Percentage of acquired malapposed struts at bifurcation segments	12 months post-procedure
Instent late-lumen loss by quantitative coronary analysis	12 months post-procedure

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan