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.
Age ≥18 years;
stable ischemic heart disease or
acute coronary syndrome (non-ST-segment elevation myocardial infarction [NSTEMI] or unstable angina), or
stabilized recent ST-segment elevation myocardial infarction (STEMI) (>48 hours prior to enrollment);
Clinical exclusion criteria：
Subject has undergone PCI in the target vessel or its branches within 12 months prior to randomization or prior CABG any time;
Subject has undergone a PCI procedure in a non-target vessel that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. Successful and uncomplicated PCI is defined as final diameter stenosis ≤20% with final TIMI-3 flow, no residual dissection grade≥ type B, no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting >5 minutes, and no ST-segment elevation or depression lasting >5 minutes);
PCI is planned within 12 months post randomization aside from a potential planned staged PCI as part of the randomized treatment strategy;
Factorial
IVL Pretreatment + OCT-Guided Stent Implantation
DeviceSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
IVL Pretreatment + Angiography-Guided Stent Implantation
DeviceSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation
DeviceSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent Implantation
DeviceSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
Target Vessel Failure (TVF) at 3 years
Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (iTVR) at 3 years, assessed when the last enrolled patient reaches 1-year follow-up
TVF （Target Vessel Failure ）(at 1 and 2 years)
Target Lesion Failure (TLF)
defined as composite of cardiac death, TVMI, or ischemia-driven target lesion revascularization (iTLR); 3.Major Adverse Cardiovascular Events (MACE), defined as cardiac death, all MI, or TVR;
Major Adverse Cardiovascular Events (MACE)
defined as cardiac death, all MI, or TVR;
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
including all-cause death, MI, stroke, or any revascularization;
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