REGADENOSON for Chronic total occlusion of coronary artery

Inclusion criteria

• {"criterion_text":"-Chronic total occlusion in a native coronary artery\n-Age 18 years or older\n-Distal vessel to the chronic occlusion with a diameter of at least 2.5 mm\n-Ability to provide informed consent and willingness to comply with the follow-up protocol"}

Exclusion criteria

• {"criterion_text":"-Multivessel disease with incomplete revascularization in the artery without chronic total occlusions.\n-Severe valvular disease requiring surgery.\n-Allergy to iodinated contrast.\n-Previous revascularization surgery in the artery with chronic total occlusion.\n-Acute myocardial infarction within the past 3 months.\n-Coronary anatomy not favorable for percutaneous revascularization of the chronic total occlusion.\n-Coronary artery disease involving the left main or three vessels requiring surgery as assessed by the multidisciplinary team.\n-Life expectancy less than 2 years.\n-Severe chronic renal insufficiency (glomerular filtration rate ≤ 30 mL/min).\n-Contraindication to dual antiplatelet therapy.\n-Pregnancy."}

Primary endpoints

• {"endpoint_text":"-Viability: -Enhancement Criterion: mean late enhancement in more than 50% of the thickness of the affected myocardial wall using the 17-segment model. Number of segments meeting this criterion. -Myocardial Thickness Criterion: mean myocardial thickness less than 5 or 3 mm in segments with motility impairment. Number of segments meeting this criterion.","definition_or_measurement_approach":"Measurement by late enhancement and myocardial thickness using the 17-segment model; count number of segments meeting the enhancement (>50% thickness) and myocardial thickness (<5 or 3 mm) criteria."}
• {"endpoint_text":"-Myocardial Ischemia: Inducible and persistent perfusion defect during the stress study that significantly improves or completely resolves in the rest study and exceeds the lateral or transmural extent of myocardial scar in the late enhancement study in the same myocardial segment. Number of segments with myocardial ischemia.","definition_or_measurement_approach":"Defined as inducible and persistent perfusion defect on stress imaging that improves or resolves at rest and exceeds scar extent on late enhancement in same segment; outcome is number of segments with myocardial ischemia."}
• {"endpoint_text":"-Chronic Total Occlusion (CTO): Absence of antegrade coronary flow through the coronary stenosis. There may be flow through ipsilateral collaterals as long as there is no flow through the lesion. The CTO will be classified as definite if there is evidence of an occlusion lasting more than three months. If there is no evidence regarding the duration of the occlusion, it will be classified as probable.","definition_or_measurement_approach":"CTO defined by absence of antegrade coronary flow through the stenosis; classified as definite if evidence of occlusion >3 months, otherwise probable."}

Secondary endpoints

• {"endpoint_text":"-Cardiac Magnetic Resonance Imaging (CMR): A baseline study will be performed and 6 months after the intervention according to routine clinical practice. All studies will be conducted on a 3T system (ARCHITECT GE).","definition_or_measurement_approach":"Baseline and 6-month follow-up CMR performed on a 3T system (ARCHITECT GE) according to routine clinical practice."}
• {"endpoint_text":"-Computed Tomography: A Computed Tomography study will be performed as part of routine clinical practice within the pre-procedural evaluation of percutaneous coronary revascularization. A protocol will be conducted that includes a static perfusion assessment at stress and rest, coronary angiography, and late enhancement for viability evaluation. A dual-source scanner with dual-energy capability (Somaton Flash Definition, SIEMENS) will be used.","definition_or_measurement_approach":"Pre-procedural CT including static perfusion at stress and rest, coronary angiography, and late enhancement for viability using a dual-source dual-energy scanner (Somaton Flash Definition, SIEMENS)."}
• {"endpoint_text":"-Adverse Events: The definitions provided by the Chronic Total Occlusion Academic Research Consortium (CTO-ARC) will be used.","definition_or_measurement_approach":"Adverse events classified/defined according to CTO-ARC definitions."}
• {"endpoint_text":"-Arrhythmogenic Substrate: The evaluation of the arrhythmogenic substrate will be performed using late enhancement images obtained through a 3D Inversion-Recovery Gradient Echo sequence with free-breathing and respiratory navigator. The ADAS 3D software from Galgo Medical SL with CE marking will be used.","definition_or_measurement_approach":"Arrhythmogenic substrate assessed from late enhancement 3D inversion-recovery gradient echo sequences with free-breathing respiratory navigator; analysis using ADAS 3D software (Galgo Medical SL)."}
• {"endpoint_text":"-Invasive Physiological Assessment: Invasive physiological assessment will be performed in all patients according to routine clinical practice with the aim of optimizing percutaneous treatment. Follow-up catheterization with invasive physiological assessment in patients with distal stenosis to the occlusion ≥ 50% will also be performed according to routine clinical practice (substudy of invasive coronary physiology).","definition_or_measurement_approach":"Invasive physiological assessment performed per routine practice in all patients; follow-up catheterization with physiological assessment for patients with distal stenosis ≥50% as a substudy."}

Spain

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

10-01-2025

Processing Time Days

21

Number Of Sites

1

Number Of Participants

78

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain