Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention (OCTIVUS)

• ClinicalTrials.gov Identifier: NCT03394079
• Recruitment Status: Active, not recruiting
• First Posted: January 9, 2018
• Last Update Posted: June 23, 2023
• Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Information provided by (Responsible Party): Seung-Jung Park, Asan Medical Center

Tracking Information

• First Submitted Date: December 25, 2017
• First Posted Date: January 9, 2018
• Last Update Posted Date: June 23, 2023
• Actual Study Start Date: April 12, 2018
• Actual Primary Completion Date: February 17, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2023)

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.

Original Primary Outcome Measures (submitted: January 3, 2018)

Target vessel failure [ Time Frame: 1 year ]

the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target vessel revascularization at 1 year after the index procedure

Current Secondary Outcome Measures (submitted: June 22, 2023)

• Rate of cardiac Death [ Time Frame: 1, and 5 years ]
• Rate of target vessel myocardial infarction [ Time Frame: 1, and 5 years ]
• Rate of ischemia-driven target vessel revascularization [ Time Frame: 1, and 5 years ]
• Rate of death [ Time Frame: 1, and 5 years ]
  cardiac, vascular, non-cardiovascular death
• Rate of myocardial infarction [ Time Frame: 1, and 5 years ]
  periprocedural or spontaneous, Q-wave or non-Q-wave.
• 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.
• 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.
• 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.
• Rate of any hospitalization [ Time Frame: 1, and 5 years ]
  Cardiac or non-cardiac causes.
• 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.
• Rate of target-lesion failure [ Time Frame: 1, and 5 years ]
  Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: January 3, 2018)

• Device success [ Time Frame: 1 hour ]
  Lesion level analysis : Successful PCI at the intended target lesion with final instant residual stenosis of less than 30% by quantitative coronary angiography (QCA)
• Death [ Time Frame: 1, and 5 years ]
  cardiac, vascular, non-cardiovascular death
• Myocardial infarction [ Time Frame: 1, and 5 years ]
  periprocedural/spontaneous MI
• Stent thrombosis [ Time Frame: 1, and 5 years ]
  definite/probable
• Stroke [ Time Frame: 1, and 5 years ]
• Any revascularization [ Time Frame: 1, and 5 years ]
• Target lesion revascularization [ Time Frame: 1, and 5 years ]
• Target vessel revascularization [ Time Frame: 1, and 5 years ]
• Repeat hospitalization [ Time Frame: 1, and 5 years ]
• Acute kidney injury [ Time Frame: 7 days ]
  after index procedure before discharge
• Target lesion failure [ Time Frame: 1, and 5 years ]
  cardiac death, target vessel MI or ischemia-driven TLR
• A composite event of all-cause death and spontaneous MI [ Time Frame: 1, and 5 years ]
  A composite event of all-cause death and spontaneous MI is defined as the occurrence of either all-cause death, spontaneous MI, or both and denoted that event as the union of endpoint all-cause death and endpoint spontaneous MI.
• A composite of cardiac death and spontaneous MI [ Time Frame: 1, and 5 years ]
  A composite event of cardiac death and spontaneous MI is defined as the occurrence of either cardiac death, spontaneous MI, or both and denoted that event as the union of endpoint cardiac death and endpoint spontaneous MI.
• A composite of all-cause death, any MI, any repeat revascularization [ Time Frame: 1, and 5 years ]
  A composite event of all-cause death, any MI, any repeat revascularization is defined as the occurrence of any event from all-cause death, any MI, any repeat revascularization and denoted that event as the union of endpoint all-cause death, endpoint any MI, and endpoint any repeat revascularization.
• A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding [ Time Frame: 1, and 5 years ]
  A composite event of cardiac death, target vessel MI, stroke, or clinically significant bleeding is defined as the occurrence of any event from cardiac death, target vessel MI, stroke, clinically significant bleeding and denoted that event as the union of endpoint cardiac death, endpoint target vessel MI, endpoint stroke, and endpoint clinically significant bleeding. clinically significant bleeding : Bleeding Academic Research Consortium (BARC) type 2,3,4,5

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Vessels

Intervention

Procedure: PCI

Percutaneous Coronary Intervention

Study Arms

• Experimental: OCT-guided
  Intervention: Procedure: PCI
• Active Comparator: IVUS-guided
  Intervention: Procedure: PCI

• Publications *: Kang DY, Ahn JM, Park H, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Kim SW, Hur SH, Cho YK, Lee CH, Hong SJ, Hong YJ, Yoon YW, Kim SJ, Bae JH, Oh JH, Park DW, Park SJ. Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. Am Heart J. 2020 Oct;228:72-80. doi: 10.1016/j.ahj.2020.08.003. Epub 2020 Aug 8.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 24, 2023): 2008
• Original Estimated Enrollment (submitted: January 3, 2018): 2000
• Estimated Study Completion Date: January 31, 2028
• Actual Primary Completion Date: February 17, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03394079
• Other Study ID Numbers: AMCCV2017-10
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Seung-Jung Park, Asan Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Seung-Jung Park
• Original Study Sponsor: Same as current
• Collaborators: CardioVascular Research Foundation, Korea

Investigators

• Principal Investigator: Duk-woo Park, MD; Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

• PRS Account: Asan Medical Center
• Verification Date: June 2023