Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
brief summary
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment. The LOCATION Study is a large clinical study designed to compare different commonly used treatment strategies for patients with severely calcified coronary arteries who need a coronary stent. The study aims to find safer and more effective ways to prepare the artery and place the stent in order to improve long-term outcomes. In this study, participants will be randomly assigned (like flipping a coin) to one of four treatment groups during their coronary procedure. The treatments differ in two ways: (1) how the calcified artery is prepared before placing the stent, and (2) how imaging is used to guide stent placement. One method uses a shockwave-based device to help break calcium in the artery, while the other uses standard balloon treatment. For imaging guidance, one approach uses a high-resolution imaging catheter inside the artery, and the other relies on standard X-ray imaging. All participants will receive a standard, approved drug-eluting stent as part of routine care. The main goal of the study is to determine which treatment approach best reduces serious heart-related problems over three years. These problems include heart-related death, heart attack in the treated vessel, or the need for another procedure on the same vessel. Adults aged 18 years or older with significant coronary artery narrowing and severe calcium buildup may be eligible to participate. All participants must provide written informed consent before joining the study. Participants will be followed during their hospital stay and through regular follow-up visits or phone calls for up to three years after the procedure. Information collected during the study will help doctors better understand how to treat patients with severely calcified coronary arteries in the future. Participation in this study is voluntary, and patients may withdraw at any time without affecting their medical care. All study devices used in this trial are approved for clinical use, and patient privacy will be protected according to applicable regulations.
detailed description
LOCATION Study is a prospective, multicenter, 2x2 factorial randomized controlled trial.
Number of Sites: Approximately 50 sites in China.
Trial Objectives:
Objective 1: To evaluate the efficacy and safety of coronary intravascular lithotripsy (IVL) compared with balloon angioplasty (BA) for pretreatment of severely coronary calcified lesions prior to implantation of stents.
Objective 2: To evaluate the efficacy of optical coherence tomography (OCT)-guided compared with angiography-guided stent implantation in severely coronary calcified lesions.
Trial Hypotheses:
Hypotheses 1: IVL pretreatment of severely calcified coronary artery lesions will reduce the 3-year risk of target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction \[TVMI\], or clinically-driven target vessel revascularization \[TVR\]) compared with BA pretreatment.
Hypotheses 2: OCT-guided percutaneous coronary intervention (PCI) will reduce 3-year risk of TVF compared with angiography-guided PCI in severely coronary calcified lesions.
Trial Population:Patients with one or more angiographically severely calcified coronary lesions
Trial Devices:
IVL device: SoniCrackerTM Coronary IVL Therapy System (Shanghai Bluesail Boyuan Medical Technology co., Ltd) BA Devices: standard commercially approved balloon angioplasty devices including high-pressure balloons, scoring balloons, and cutting balloons, without brand restriction OCT device: Intravascular Imaging System (Nanjing Forssmann Medical Technology Co., Ltd)
Follow-up Visits:
Follow-up will range between 1-year minimum and 3-year maximum. Follow-up will be conducted at discharge, at 30 (±7) days, 180 (±7) days, at 1 year (±30 days), 2 years (±30 days), at 3 (±30 days) years with clinic visit or phone calls. When the last patient reaches 1 year follow-up, an additional "sweep visit" will be performed in all patients who have not had follow-up within 30 days. Additional visits will not be performed after this sweep visit.