Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study
This is an investigator-initiated, prospective, single-centre, non-randomized, all-comers registry that evaluates the safety and efficacy of any Paclitaxel Drug-Coated Balloon (DCB) for the treatment of coronary de novo lesion, in-stent restenosis, and small vessel disease in patients with coronary artery disease in Hong Kong. The recruitment time frame of this study is 1 year from 1st January 2022 to 30th December 2022.
• Subject age \>18.
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
• Indication for a percutaneous intervention in native epicardial arteries or bypass graft including patients with stable coronary artery disease and acute coronary syndromes (non- ST-elevated myocardial infarction and ST-elevation myocardial infarction).
• Target lesion must have a stenosis of \>50% and \<100% angiographically.
• Target lesion much have an angiographic reference vessel diameter of 2.0-4.0 mm.
• Successful predilatation of the target lesions as defined by angiographic visual estimate of \<30% residual stenosis without major (defined as \>NHLBI grade B) flow-limiting dissection.
• Target lesion must have a Thrombolysis in Myocardial Infarction flow \>2 before applying DCB.