Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Coronary Vessels Clinical Trial

— OCTIVUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03394079
• Other study ID #: AMCCV2017-10
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: January 31, 2028

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2008
• Est. completion date: January 31, 2028
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Vessels

Intervention

Procedure:
• PCI
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Hospital	Seoul
Korea, Republic of	Chung-Ang university hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung hee university hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of target vessel failure	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.	1 year
Secondary	Rate of cardiac Death		1, and 5 years
Secondary	Rate of target vessel myocardial infarction		1, and 5 years
Secondary	Rate of ischemia-driven target vessel revascularization		1, and 5 years
Secondary	Rate of death	cardiac, vascular, non-cardiovascular death	1, and 5 years
Secondary	Rate of myocardial infarction	periprocedural or spontaneous, Q-wave or non-Q-wave.	1, and 5 years
Secondary	Rate of stent thrombosis	Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.	1, and 5 years
Secondary	Rate of stroke	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.	1, and 5 years
Secondary	Rate of repeat revascularization	Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.	1, and 5 years
Secondary	Rate of any hospitalization	Cardiac or non-cardiac causes.	1, and 5 years
Secondary	Rate of bleeding events	Life-threatening or disabling, major bleeding, or minor.; Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.	1, and 5 years
Secondary	Rate of target-lesion failure	Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization	1, and 5 years
Secondary	Rate of contrast-induced acute kidney injury	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.	3 days
Secondary	Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices	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.	1 day
Secondary	Rate of angiographic or imaging-based device success	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.	1 day