NCT04444037

Brief Summary

Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 20, 2020

Last Update Submit

June 22, 2020

Conditions

Acute Coronary Syndrome

Keywords

OCT, stent implantation

Outcome Measures

Primary Outcomes (1)

  • Percent difference in lumen expansion in stent treated lesion

    Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.

    Immediately after the procedure

Secondary Outcomes (1)

  • Clinical outcomes at 1 year follow up

    During 1 year following the index procedure

Study Arms (2)

OCT-guided PCI

PCI procedure was done with intra-coronary imaging OCT.

Device: OCT-guided PCI

Angiography-guided PCI

PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone

Interventions

OCT-guided PCIDEVICE

using optical coherence tomography imaging to help PCI procedure

OCT-guided PCI

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient either underwent PCI with angiography alone or OCT guided and is grouped accordingly

You may qualify if:

  • Patients presented with acute coronary syndrome.
  • PCI was done to them with stent implantation.

You may not qualify if:

  • Multivessel PCI at the index procedure.
  • Patients with ACS due to graft failure post CABG.
  • Patients treated with no stent implantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wakayama Medical University

Wakayama, 641-8509, Japan

Location

Related Publications (8)

  • Wu S, Liu W, Guo Y, Zeng Y, Zhou Z, Zhao Y, Liu Y, Shi D, Wang Z, Ge H, Wang J, Jin P, Zhou Y. The impact of acute coronary syndrome on late drug-eluting stents restenosis: Insights from optical coherence tomography. Medicine (Baltimore). 2017 Dec;96(52):e9515. doi: 10.1097/MD.0000000000009515.

    PMID: 29384957BACKGROUND

  • Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.

    PMID: 29121226BACKGROUND

  • Khalifa AKM, Kubo T, Ino Y, Terada K, Emori H, Higashioka D, Katayama Y, Takahata M, Shimamura K, Shiono Y, Matsuo Y, Tanaka A, Hozumi T, Akasaka T. Optical Coherence Tomography Comparison of Percutaneous Coronary Intervention Among Plaque Rupture, Erosion, and Calcified Nodule in Acute Myocardial Infarction. Circ J. 2020 May 25;84(6):911-916. doi: 10.1253/circj.CJ-20-0014. Epub 2020 Apr 18.

    PMID: 32307358BACKGROUND

  • Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Ino Y, Kitabata H, Shimokawa T, Akasaka T. Comparison between Optical COherence tomography guidance and Angiography guidance in percutaneous coronary intervention (COCOA): Study protocol for a randomized controlled trial. J Cardiol. 2018 Aug;72(2):170-175. doi: 10.1016/j.jjcc.2018.01.005. Epub 2018 Mar 2.

    PMID: 29486964BACKGROUND

  • Otake H, Kubo T, Shinke T, Hibi K, Tanaka S, Ishida M, Kataoka T, Takaya T, Iwasaki M, Sonoda S, Ioji T, Akasaka T. OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial. J Cardiol. 2020 Sep;76(3):317-321. doi: 10.1016/j.jjcc.2020.03.010. Epub 2020 Apr 24.

    PMID: 32340781BACKGROUND

  • TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.

    PMID: 4038784BACKGROUND

  • Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.

    PMID: 27806900BACKGROUND

  • Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

    PMID: 27573032BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeOrnithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesUrea Cycle Disorders, InbornBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yehia T Kishk, MD

    Assiut University

    STUDY CHAIR

  • Hossam H Ali, MD

    Assiut University

    STUDY CHAIR

  • Ahmed Abdel-Galeel, MD

    Assiut University

    STUDY CHAIR

  • Takashi Akasaka, MD, PhD

    Wakayama Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, Cardiology department

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

January 1, 2019

Primary Completion

March 31, 2020

Study Completion

April 30, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Nothing

Locations

JP(1)