High-Pressure Cutting Balloons versus Other Modified Balloons for Coronary Artery Calcified Lesions: A Randomized Controlled Superiority Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Experimental group (High‐pressure cutting balloon group):In the experimental group (high‐pressure cutting balloon group), the lesions were pretreated with a high‐pressure cutting balloon prior to DES implantation.;Control group:Prior to scheduled DES implantation, the control group may select any commercially available non‐cutting modified balloon, including spiked, papillary, or notched balloons; the pretreatment strategy and sequence are determined by the operator.; CONDITION: Coronary artery heart disease PRIMARY OUTCOME: Minimum stent area at the site of maximum calcification immediately after stent implantation and before post‐expansion; SECONDARY OUTCOME: Procedural success rate;Strategy success rate;Myocardial infarction;In‐stent thrombosis;30‐day MACE;Cardiac death;In ‐ hospital major adverse cardiac events;Minimum stent area at the site of maximum calcification after stent implantation and post‐expansion;Stent expansion; INCLUSION CRITERIA: 1.Age >= 18 years; 2.Patients with coronary artery disease who meet the indications for drug‐eluting stent implantation under intravascular ultrasound (IVUS) guidance; 3.Moderate‐to‐severe calcified lesions confirmed by coronary angiography; 4.The target lesion is a de novo vascular lesion without any prior interventional treatment history; 5.The target vessel diameter ranges from 2.5 to 4.0 mm, and the guidewire has successfully crossed the target lesion; 6.For patients with multiple lesions, only one lesion will be designated as the target lesion. In cases where both target and non‐target lesions require concurrent treatment, they must be located in distinct vascular branches. The non‐target lesion must be addressed first; the target lesion intervention may be initiated only after successful revascularization of the non‐target lesion and in the absence of severe angiographic complications; 7.Informed consent has been signed by the patient or thei
Epistemonikos ID: ec9a46f4219198c18b330c6919929177ed2b16d6
First added on: Oct 08, 2026