Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions

Prior treatment

• History of stroke or Transient Ischemic Attack (TIA) within the previous 3 months.
• Target lesion is a CTO within a previously stented segment (In-Stent Restenosis \[ISR\] or In-Stent Thrombosis \[IST\]).
• Concurrent enrollment in another interventional clinical trial that may interfere with the study endpoints or assessments.

Other illness

• Target CTO lesion is the culprit vessel responsible for the presenting Acute Myocardial Infarction (AMI).
• Known high risk of bleeding or contraindication to Dual Antiplatelet Therapy (DAPT).
• Known hypersensitivity or contraindication to required study medications (e.g., antiplatelet agents, contrast media), DCB/DES drug coatings, or device materials (e.g., stent alloys, polymers).
• Failed attempt at CTO recanalization during the index procedure (i.e., failure to cross the lesion with a guidewire or failure to restore TIMI grade 3 flow).
• Occurrence of a complication after vessel preparation that necessitates immediate stent implantation (e.g., flow-limiting dissection, perforation requiring a covered stent).

Lab values

• Presence of severe heart failure (New York Heart Association \[NYHA\] Class IV) or Left Ventricular Ejection Fraction (LVEF) \< 30%.
• Presence of severe hepatic impairment and/or severe renal impairment (e.g., estimated Glomerular Filtration Rate \[eGFR\] \< 30 ml/min/1.73m² or requirement for chronic dialysis).

Other

• Patient is in cardiogenic shock.
• Target lesion located in an unprotected left main coronary artery, a saphenous vein graft, or an arterial graft.
• Presence of severe lesion calcification that prevents adequate vessel expansion despite attempted lesion preparation techniques (e.g., rotational atherectomy, intravascular lithotripsy).
• Female patient is pregnant or breastfeeding.
• Patient judged by the investigator to be unsuitable for the study for any reason, including anticipated poor compliance with the protocol.

• Patient voluntarily participates in the study and has provided written informed consent.
• Presence of clinical indication for Percutaneous Coronary Intervention (PCI) of the Chronic Total Occlusion (CTO) (e.g., symptoms of angina pectoris or evidence of myocardial ischemia).
• Target lesion is located in a de novo coronary artery.
• Angiographically confirmed CTO (TIMI grade 0 flow), with evidence supporting an occlusion duration of ≥ 3 months.
• Successful guidewire crossing of the target CTO lesion has been achieved during the index procedure.
• After adequate vessel preparation: Distal TIMI grade 3 flow has been restored; Target lesion residual diameter stenosis is \< 50% (e.g., by visual estimate or QCA as per protocol); Absence of flow-limiting dissection or other complications requiring immediate stent implantation.
• Target vessel Reference Vessel Diameter (RVD) is between 2.25 mm and 4.0 mm (inclusive, assessed by visual estimate or QCA/IVUS as per protocol).
• In the judgment of the interventional operator, the lesion is deemed suitable for treatment with both a Drug-Coated Balloon (DCB)-based strategy and a Drug-Eluting Stent (DES)-only strategy.
• Patient is able and willing to comply with the study protocol requirements, including the specified follow-up schedule.
• Female patients of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use an effective method of contraception throughout the study period.