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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02796157

Enrollment

950

Registered

2016-06-10

Start date

2016-06-30

Completion date

2019-05-31

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

bioresorbable vascular scaffold, drug eluting stent, coronary artery disease

Brief summary

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.

Interventions

DEVICEPCI with Absorb everolimus-eluting bioresorbable vascular scaffold

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.

DEVICEPCI with Xience everolimus-eluting metallic stent

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026