Coronary Artery DiseasePhase 2MISTIC-1NCT03292081
Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation
A Phase 2 study testing OFDI and IVUS in people with Coronary Artery Disease, run by Fujita Health University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OFDI and IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteJapan
- Study dates
- 12 Jun 2014to 25 Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation
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.
Read the detailed description
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
- Coronary Artery Disease
- Being tested
- OFDI, IVUS
- Keywords
- Intracoronary Imaging, Optical Frequency Domain Imaging, Intravascular Ultrasound, Percutaneous Coronary Intervention, Drug Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFDIDevice
Also called LUNAWAVE imaging console, Fastview imaging catheter
PCI under OFDI guidance
IVUSDevice
Also called VISIWAVE imaging console, ViewIT imaging catheter
PCI under IVUS guidance
| Study group | Role | What they receive |
|---|---|---|
| OFDI-guided PCI | Experimental | Not described Receives: Device: OFDI |
| IVUS-guided PCI | Active comparator | Not described Receives: Device: IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum lumen area assessed by OFDI
Measured: 8 months
Secondary outcomes (6)
Cardiovascular mortality
Measured: 8 months
Target vessel myocardial infarction
Measured: 8 months
Target lesion revascularization
Measured: 8 months
Apposition of stent struts assessed by OFDI
Measured: 8 months
Tissue coverage of stent struts assessed by OFDI
Measured: 8 months
Quantitative Coronary Angiography (QCA)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start12 Jun 2014
- Primary completion31 Jul 2016
- Study completion25 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujita Health University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Ozaki, Fujita Health University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292081
- Sponsor's protocol ID
- 14-106
- Acronym
- MISTIC-1
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33106049
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT03292081
- Acronym / sponsor ID
- MISTIC-1 / 14-106
- Conditions
- Coronary Artery Disease
- Keywords
- Intracoronary Imaging, Optical Frequency Domain Imaging, Intravascular Ultrasound, Percutaneous Coronary Intervention, Drug Eluting Stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fujita Health UniversityUniversity, hospital or other
- Study start
- 12 Jun 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 25 Oct 2017 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFDI-guided PCI | Experimental | Device: OFDI |
| IVUS-guided PCI | Active comparator | Device: IVUS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFDIAlso: LUNAWAVE imaging console, Fastview imaging catheterPCI under OFDI guidance | Device | OFDI-guided PCI |
| IVUSAlso: VISIWAVE imaging console, ViewIT imaging catheterPCI under IVUS guidance | Device | IVUS-guided PCI |
Primary outcome
Minimum lumen area assessed by OFDI
Time frame: 8 months
6 secondary outcomes
Cardiovascular mortality
Time frame: 8 months
Target vessel myocardial infarction
Time frame: 8 months
Target lesion revascularization
Time frame: 8 months
Apposition of stent struts assessed by OFDI
Time frame: 8 months
Tissue coverage of stent struts assessed by OFDI
Time frame: 8 months
Quantitative Coronary Angiography (QCA)
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 33106049Muramatsu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OFDI and IVUS in people with Coronary Artery Disease, run by Fujita Health University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum lumen area assessed by OFDI (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.