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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Percentage of stent strut coverage at bifurcation segments
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ying-Chang Tung
Assistant Professor, Department of Cardiology
Chang Gung Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
- •Patients who are suitable for PCI with DES implantation and provide written informed consent.
- •Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
- •Target vessels suitable for OCT examination.
- •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
- •Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
- •Estimated glomerular filtration rate \< 45 ml/min/1.73 m2
- •Liver cirrhosis
- •Life expectancy \< 1 year
- •Planned surgery within 3 months
- •Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
- •Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
Outcomes
Primary Outcomes
Percentage of stent strut coverage at bifurcation segments
Time Frame: 3 months post-procedure
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)