Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS (INTERCLIMA)
Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Optical coherence tomography, Vulnerable plaque
Eligibility Criteria
Inclusion Criteria:
- Age of at least 18 years.
- Diagnosis of acute coronary syndrome.
- Single intermediate lesion in an intervention-naïve major coronary segment (diameter ≥2.5 mm) determining a 40-70% diameter stenosis at quantitative coronary angiography analysis with no other significant stenosis (>70%) in the same vessel.
- Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
- Life expectancy >3 years.
Exclusion criteria:
- Female with childbearing potential or lactating.
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
- Advanced heart failure (NYHA III-IV)
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
- Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
- Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
- Prior myocardial infarction or coronary artery bypass graft [CABG] or PCI revascularization in the target coronary vessel.
- Coronary anatomy unsuitable for PCI.
- Comorbidities that might interfere with completion of the study procedures.
- Planned major surgery necessitating interruption of dual antiplatelet.
- Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
Sites / Locations
- San Giovanni HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intermediate lesion OCT-based management
Intermediate lesion physiology-based management
At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following: FCT <75 µm, plus at least 2 of 3 other OCT criteria of plaque vulnerability (i.e., MLA <3.5 mm2, lipid arc with circumferential extension >180°, and the presence of macrophages). The presence of intracoronary thrombus at a non-culprit site, irrespective of the presence of other vulnerability criteria, may prompt treatment with DES, at the operator's discretion. All lesions fulfilling these interventional criteria will be treated with an OCT guided DES implantation in order to achieve an optimal stent implantation. In presence of a MLA <2.0 mm2, best cut-off showing correlation with fractional-flow reserve positive functional (FFR) assessment, clinical decision whether to treat the lesion will be based on FFR assessment irrespective of the presence of other criteria of vulnerability. Alternatively authors will have the option to treat the lesion with a DES.
The iFR/FFR/RFR measurements will be obtained using a coronary-pressure guidewire. For FFR, hyperemia will be induced with the administration of intravenous adenosine, in accordance with the clinical practice at each participating center. Lesion features prompting intervention instead of conservative medical approach will be the following: iFR ≤0.89, or FFR ≤0.80.(32) All lesions fulfilling these interventional criteria will be treated with an FFR guided DES implantation. PCI will be performed with the aim of achieving a post-stenting FFR ≥0.90 (i.e. optimal FFR result). If post-stenting FFR was <0.90 a further post-dilation of the stent could be performed and if FFR remained at <0.90, a pullback of the wire to identify another possible pressure drop and/or a subsequent stent implantation at least 5 mm from the stent will be performed according to physician's preference.