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Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation

NCT ID: NCT03292081

Last Updated: 2017-09-25

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-12

Study Completion Date

2017-10-25

Brief Summary

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The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.

Detailed Description

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Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences suggest potential advantage of intracoronary imaging guidance in reducing the risk of major adverse cardiac events after stent implantation over conventional PCI under angiographic guidance alone. IVUS has been clinically used in two decades and it is known as one of the most dominant intracoronary imaging technique. OFDI is a new light-based intracoronary imaging technology which provides higher image resolution and higher-speed pullback compared to those of IVUS. Given the different properties between ultrasound-based IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques would be different.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OFDI-guided PCI

Group Type EXPERIMENTAL

OFDI

Intervention Type DEVICE

PCI under OFDI guidance

IVUS-guided PCI

Group Type ACTIVE_COMPARATOR

IVUS

Intervention Type DEVICE

PCI under IVUS guidance

Interventions

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OFDI

PCI under OFDI guidance

Intervention Type DEVICE

IVUS

PCI under IVUS guidance

Intervention Type DEVICE

Other Intervention Names

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LUNAWAVE imaging console Fastview imaging catheter VISIWAVE imaging console ViewIT imaging catheter

Eligibility Criteria

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Inclusion Criteria

* Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.

Exclusion Criteria

* Renal insufficiency with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2
* Left ventricular ejection fraction (LVEF) \<30% or history of congestive heart failure
* Acute coronary syndrome within 7 days after onset
* Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet therapy for one year after the index procedure
* Life expectancy within one year
* Lesion length estimated by quantitative coronary angiography (QCA) \>28mm
* Chronic total occlusion
* Left main stem lesion
* Bifurcation requiring side branch balloon dilatation
* Severely calcified lesion
* Other conditions by which physicians in charge judged inappropriate to enroll the patients because of safety concern.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujita Health University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Ozaki

Professor, Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujita Health University

Toyoake, , Japan

Site Status

Countries

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Japan

References

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Muramatsu T, Ozaki Y, Nanasato M, Ishikawa M, Nagasaka R, Ohota M, Hashimoto Y, Yoshiki Y, Takatsu H, Ito K, Kamiya H, Yoshida Y, Murohara T, Izawa H; MISTIC-1 Investigators. Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009314. doi: 10.1161/CIRCINTERVENTIONS.120.009314. Epub 2020 Oct 27.

Reference Type DERIVED
PMID: 33106049 (View on PubMed)

Other Identifiers

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14-106

Identifier Type: -

Identifier Source: org_study_id