A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions

Study Overview
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Brief Summary
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PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
* Device: PCI with Xience everolimus-eluting metallic stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19-85 years Patients with ischemic heart disease requiring PCI Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation Reference vessel diameter of 2.5 to 3.75 mm by operator assessment Exclusion Criteria: Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique Contraindication or hypersensitivity to anti-platelet agents or contrast media Treated with any metallic stent or BVS within 3 months at other vessel Cardiogenic shock Left ventricular ejection fraction <40% Pregnant women or women with potential childbearing Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Inability to understand or read the informed content

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: absorb arm<br>PCI with Absorb everolimus-eluting bioresorbable vascular scaffold | Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold<br>* Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.<br>|
| Experimental: Xience arm<br>PCI with Xience everolimus-eluting metallic stent | Device: PCI with Xience everolimus-eluting metallic stent<br>* Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite of major adverse cardiovascular events | Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR) | 1 year after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioresorbable vascular scaffold, drug eluting stent, coronary artery disease