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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

NCT02831205

Percutaneous Transluminal Coronary Angioplasty

TERMINATED PHASE4

A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

NCT02579031

Coronary Artery Disease Acute Coronary Syndrome

COMPLETED NA

A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI

NCT03440801

STEMI - ST Elevation Myocardial Infarction

COMPLETED NA

ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis

NCT02486068

Coronary Artery Lesion

UNKNOWN NA

Everolimus- Versus Biolimus-Eluting Stents in All-Comers

NCT01472705

Coronary Artery Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

absorb arm

PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Group Type ACTIVE_COMPARATOR

PCI with Absorb everolimus-eluting bioresorbable vascular scaffold

Intervention Type DEVICE

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.

Xience arm

PCI with Xience everolimus-eluting metallic stent

Group Type EXPERIMENTAL

PCI with Xience everolimus-eluting metallic stent

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PCI 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.

Intervention Type DEVICE

PCI 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No