Lesion preparation comparison for drug-coated balloon angioplasty: the NATURE study

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2024
INTERVENTION: 1. Randomly assign to either "cutting balloon" or "normal balloon" for lesion preparation procedure 2. Use AgentTM(Paclitaxel Coated‐PTCA Balloon Catheter ) for the DCB target de novo lesion of 2.5‐4.0mm diameter CONDITION: D017202 Ichemic heart disease with PCI indication ; Ischemic heart disease PRIMARY OUTCOME: Achievement rate of DCB use criteria (based on the international DCB consensus group) determined by 1) angiographic results evaluated at core lab and 2) FFR measured during PCI SECONDARY OUTCOME: 1. Clinically assessed success rate of DCB use; 2. Number, ratio, and survival curve of clinical events; 3. Number and ratio of composite events compared between each of the randomized groups; 4. Number and ratio of late lumen enlargement 9 months after the inde XPCI in the patients treated with DCB; 5. IVUS findings correlated with 12‐month composite endpoints and 9‐month late lumen enlargement; 6. Correlation between QFR and FFR after the pre‐dilatation; 7. Number and percentage of AE events in the >3.0mm lesion treated with DCB INCLUSION CRITERIA: 1. Disease Criteria (either one of followings): a. Chronic coronary syndrome with at least 90% angiographic stenosis or proven ischemia with PCI indication b. Unstable angina without troponin elevation 2. PCI target lesion is appropriate for DCB angioplasty (de novo lesion of 2.5‐4.0mm diameter and no longer than 28mm) 3. Age greater than or equal to 18 years old 4. Signed informed consent form 5. One year availability for follow up hospital visit or calls from the inde XPCI
Epistemonikos ID: 5b2c0691f087d1b1865b9e8c8a2285744c3df903
First added on: Aug 28, 2024