NCT03292081

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jun 2014

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

August 29, 2017

Last Update Submit

September 22, 2017

Conditions

Coronary Artery Disease

Keywords

Intracoronary ImagingOptical Frequency Domain ImagingIntravascular UltrasoundPercutaneous Coronary InterventionDrug Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • Minimum lumen area assessed by OFDI

    8 months

Secondary Outcomes (6)

  • Cardiovascular mortality

    8 months

  • Target vessel myocardial infarction

    8 months

  • Target lesion revascularization

    8 months

  • Apposition of stent struts assessed by OFDI

    8 months

  • Tissue coverage of stent struts assessed by OFDI

    8 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Integrated Backscatter IVUS (IB-IVUS)

    0 month (pre-procedure)

  • Detectable external elastic lamina (EEL) arc assessed by OFDI

    0 month (pre-procedure)

Study Arms (2)

OFDI-guided PCI

EXPERIMENTAL
Device: OFDI

IVUS-guided PCI

ACTIVE COMPARATOR
Device: IVUS

Interventions

OFDIDEVICE

PCI under OFDI guidance

Also known as: LUNAWAVE imaging console, Fastview imaging catheter
OFDI-guided PCI
IVUSDEVICE

PCI under IVUS guidance

Also known as: VISIWAVE imaging console, ViewIT imaging catheter
IVUS-guided PCI

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujita Health University

Toyoake, 470-1192, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33106049DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Cardiology

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 25, 2017

Study Start

June 12, 2014

Primary Completion

July 31, 2016

Study Completion

October 25, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

JP(1)