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

N/AUnknownNCT05200637

Chang Gung Memorial Hospital150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Coronary Artery Disease

Interventions

Orsiro stentDEVICE

Orsiro stent

Xience stentDEVICE

Xience stent

Any drug-eluting stentDEVICE

Any drug-eluting stent

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Outcomes

Primary Outcomes

Percentage of stent strut coverage at bifurcation segments

Time frame: 3 months post-procedure

Secondary Outcomes

Neointimal thickness (μm) at bifurcation segments

Time frame: 3 months post-procedure

Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments

Time frame: 3 months post-procedure

Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments

Time frame: 3 months post-procedure

Percentage of acquired malapposed struts at bifurcation segments

Time frame: 3 months post-procedure

Percentage of stent strut coverage at bifurcation segments