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NCT Number: NCT03394079

Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Vessels

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Medical Center, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women at least 19 years of age
  • Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

  • ST-elevation myocardial infarction
  • Severe renal dysfunction (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl), unless patient is on renal replacement therapy.
  • Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
  • Life expectancy < 1 year for any non-cardiac or cardiac causes
  • Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
  • Unwillingness or inability to comply with the procedures described in this protocol

Treatment and study plan

PCI

Procedure

Percutaneous Coronary Intervention

Primary outcomes

  1. Rate of target vessel failure

    Time frame: 1 year

    A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization.

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Secondary outcomes

  1. Rate of cardiac Death

    Time frame: 1, and 5 years

  2. Rate of target vessel myocardial infarction

    Time frame: 1, and 5 years

  3. Rate of ischemia-driven target vessel revascularization

    Time frame: 1, and 5 years

  4. Rate of death

    Time frame: 1, and 5 years

    cardiac, vascular, non-cardiovascular death

  5. Rate of myocardial infarction

    Time frame: 1, and 5 years

    periprocedural or spontaneous, Q-wave or non-Q-wave.

  6. Rate of stent thrombosis

    Time frame: 1, and 5 years

    Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.

  7. Rate of stroke

    Time frame: 1, and 5 years

    Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death.

  8. Rate of repeat revascularization

    Time frame: 1, and 5 years

    Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.

  9. Rate of any hospitalization

    Time frame: 1, and 5 years

    Cardiac or non-cardiac causes.

  10. Rate of bleeding events

    Time frame: 1, and 5 years

    Life-threatening or disabling, major bleeding, or minor.

    Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.

  11. Rate of target-lesion failure

    Time frame: 1, and 5 years

    Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

  12. Rate of contrast-induced acute kidney injury

    Time frame: 3 days

    Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 hours after PCI.

  13. Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices

    Time frame: 1 day

    Procedural complications (e.g., angiographic dissection of at least type B, coronary perforation, vasospasm, thrombus formation, air embolization, slow flow or no reflow, distal embolization, acute closure, ventricular arrhythmia, cardiac tamponade, or cardiogenic shock) requiring active interventions (prolonged balloon inflations, additional stenting required, thrombus aspiration, pericardiocentesis, cardioversion, or use of mechanical circulatory support devices), which are related to PCI procedures or intravascular imaging evaluation.

  14. Rate of angiographic or imaging-based device success

    Time frame: 1 day

    Patient- or lesion-level analysis.

    Angiographic device success is defined as successful PCI at the intended target-lesion with final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). Imaging-based device success is defined as successful PCI at the intended target-lesion, which fulfills the optimal criterial for stent implantation by IVUS or OCT.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Acronym: OCTIVUS

Important dates

Study start
2018
Primary completion
2023
Study completion
2027
First posted
Jan 9, 2018
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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