Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION

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.

Conditions

• Coronary Artery Disease
• Severe Coronary Artery Disease
• Coronary Artery Calcification

Interventions

DEVICE

IVL Pretreatment + OCT-Guided Stent Implantation

Subjects 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).

DEVICE

IVL Pretreatment + Angiography-Guided Stent Implantation

Subjects 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).

DEVICE

Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation

Subjects 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).

DEVICE

Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent Implantation

Subjects 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).

Sponsors & Collaborators

• Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yaling Han · The General Hospital of Northern Theater Command

• Gregg W. Stone · Icahn School of Medicine at Mount Sinai, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-20

Primary Completion

2030-01-20

Completion

2030-06-30

Countries

• China

Study Locations