Clinical Trial: A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063118) titled 'A Single-Center Prospective Interventional Pilot Study to Assess the Feasibility, Safety, and Change in Absolute Coronary Flow Before and After Percutaneous Coronary Intervention and Its Association With Clinical Outcomes' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Aichi Medical University

Condition: Condition - chronic coronary syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, in addition to percutaneous coronary intervention (PCI) performed as part of routine clinical care, absolute coronary flow measurements will be performed before and after PCI for research purposes. The study aims to assess the feasibility of these measurements and to exploratorily investigate the associations between changes in coronary blood flow and clinical parameters at 1-year follow-up, including symptoms, cardiac function, and B-type natriuretic peptide (BNP) levels Basic objectives2 - Others

Intervention: Interventions/Control_1 - In addition to PCI performed as part of routine clinical care, absolute coronary flow will be measured before and after PCI for research purposes. Absolute coronary flow will be measured using a PressureWire X and RayFlow catheter by continuous thermodilution with continuous saline infusion.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Age 20 years or older at the time of enrollment. 2.Scheduled to undergo percutaneous coronary intervention (PCI) for coronary artery disease. 3.Considered eligible for participation in the study by the principal investigator or a study investigator. 4.Written informed consent has been obtained from the participant. If obtaining informed consent directly from the participant is difficult, written informed consent has been obtained from a legally 5.acceptable representative. Key exclusion criteria - 1.Hemodynamic instability. 2.Ostial coronary artery lesions. 3.Severe heart failure, significant arrhythmias, or cardiogenic shock. 4.Patients in whom the study procedure is considered to pose an increased risk. 5.Coronary anatomy unsuitable for absolute coronary flow measurement. 6.History of severe hypersensitivity reactions. 7.Severe renal impairment. 8.Pregnancy or possible pregnancy. 9.Any other condition considered inappropriate for participation by the principal investigator or a study investigator. Target Size - 50

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 20 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 09 Month 30 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072253

Disclaimer: Curated by HT Syndication.