Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
1,420 participants
Jun 30, 2021
INTERVENTIONAL
Conditions
Summary
The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.
Eligibility
Inclusion Criteria5
- Age of at least 18 years.
- Diagnosis of acute coronary syndrome.
- Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment 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 Criteria13
- 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).
- Lesions located in the left main coronary artery
- 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.
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Interventions
OCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.
The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).
Locations(34)
View Full Details on ClinicalTrials.gov
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NCT05027984