Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

NCT ID: NCT04253171

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2025-11-01

Brief Summary

Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques and there is little specific evidence on how to best treat these cases. It is hypothesized that balloon lithoplasty is superior to conventional balloons for lesion preparation of severely calcified coronary lesions before stent implantation in terms of procedural failure and 1-year target vessel failure.

Detailed Description

Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques. Severe calcifications make it difficult to sufficiently prepare lesions before stenting, to advance stents, and to achieve full stent expansion. There is increased risk of vessel dissection and perforation with angioplasty on severely calcified lesions, and long-term outcomes of PCI are adversely affected. Because severely calcified lesions are often excluded from interventional studies, there is little specific evidence on how to best treat these cases. Only a few randomized studies have specifically explored this question, focusing on the use of rotational atherectomy

Recently, the technique of balloon-based lithoplasty was made commercially available. With this technique, calcifications are cracked with the creation of high-frequency pressure oscillations in a special angioplasty balloon. Standard techniques are used to deliver and dilate the balloon. The method was developed for treatment of otherwise non-dilatable lesions, and first reported results have been encouraging. The lithoplasty device used in the current study (Shockwave IVL, Shockwave Medical, CA, USA) has received CE-mark and post-approval safety has recently been confirmed for treatment of severely calcified coronary lesions in patients.

Besides obvious benefits in non-dilatable lesions for which interventional cardiologists have few other options, it is possible this technique could change the way all severely calcified lesions are treated. Balloon lithoplasty could theoretically crack plates of calcium in the vessel wall in an orderly fashion, which could lead to safer and quicker preparation of severely calcified lesions. Furthermore, a better softening of vessel wall calcium could allow full and symmetric expansion of coronary stents, which could lead to better long-term stent patency.

Conditions

Percutaneous Coronary Intervention; Coronary Artery Calcification; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lithoplasty lesion preparation

Balloon lithoplasty will be used as lesion preparation.

Group Type: ACTIVE_COMPARATOR

Lithoplasty

Intervention Type: DEVICE

The lithoplasty balloon should be utilized as early as possible. If it is necessary for passage of the lithoplasty balloon, the lesion may first be predilated with an undersized conventional balloon, non-compliant or semi-compliant. If passage of the lithoplasty balloon is still not possible, it is recommended to perform rotational atherectomy with a small burr size.

The lithoplasty balloon is sized 1:1 to reference diameter. Lithoplasty is performed with the balloon dilated at 4 atmospheres, and 10 shocks are delivered, after which the balloon is expanded to 6 atmospheres for 30 seconds, and then deflated. Up to 8 series of balloon expansion/deflation can be delivered in this manner if necessary, and several balloons may be used for long lesions.

Conventional lesion preparation

Conventional and modified balloons will be used as lesion preparation.

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: DEVICE

Lesion preparation is performed starting with conventional balloons, non-compliant or semi-compliant. Unless fully satisfactory dilatation is achieved with conventional balloons, it is recommended to also use modified balloons (scoring balloons, cutting balloons). If balloons cannot be passed or if dilatation is inadequate, the lesion may first be predilated with an undersized conventional, non-compliant, or semi-compliant balloon. If necessary, rotational atherectomy with a small burr size can be used to facilitate adequate balloon preparation.

Interventions

Lithoplasty

The lithoplasty balloon should be utilized as early as possible. If it is necessary for passage of the lithoplasty balloon, the lesion may first be predilated with an undersized conventional balloon, non-compliant or semi-compliant. If passage of the lithoplasty balloon is still not possible, it is recommended to perform rotational atherectomy with a small burr size.

The lithoplasty balloon is sized 1:1 to reference diameter. Lithoplasty is performed with the balloon dilated at 4 atmospheres, and 10 shocks are delivered, after which the balloon is expanded to 6 atmospheres for 30 seconds, and then deflated. Up to 8 series of balloon expansion/deflation can be delivered in this manner if necessary, and several balloons may be used for long lesions.

Intervention Type: DEVICE

Conventional

Lesion preparation is performed starting with conventional balloons, non-compliant or semi-compliant. Unless fully satisfactory dilatation is achieved with conventional balloons, it is recommended to also use modified balloons (scoring balloons, cutting balloons). If balloons cannot be passed or if dilatation is inadequate, the lesion may first be predilated with an undersized conventional, non-compliant, or semi-compliant balloon. If necessary, rotational atherectomy with a small burr size can be used to facilitate adequate balloon preparation.

Intervention Type: DEVICE

Other Intervention Names

Shockwave; Lithotripsy

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and < 90 years
• Stable coronary heart disease or non-ST elevation acute coronary syndrome
• PCI planned in severely calcified, non-occluded, de-novo lesion in native vessel. Definition of severe calcifications (minimum 1 of 3 (i-iii)); i. Angiography: Radioopacities of the vessel wall visible on cine images before contrast injection on both sides of the vessel lumen in more than one projection. ii. OCT (before lesion preparation): Maximum calcium 1) angle >180 degrees AND 2) thickness 0.5mm, AND 3) longitudinal length >5m m. iii. IVUS (before lesion preparation): Maximum calcium angle >270 degrees.
• Functional evidence of ischemia (non-invasive stress test or fractional flow reserve) in the target vessel territory or stenosis ≥ 90% by visual estimate
• Target vessel reference diameter visually estimated at 2.5-4 mm with ability to pass a 0.014" guidewire across lesion
• Ability to tolerate dual antiplatelet therapy
• Informed consent

Exclusion Criteria

• Unprotected left main stenosis
• Chronic total occlusion
• Severely calcified bifurcated lesion with expected need to use two stent technique
• Coronary artery dissection

• ST-segment elevation acute myocardial infarction
• Planned later revascularization in non-study lesions
• Planned cardiovascular intervention within 30 days after study intervention
• Clinical instability including decompensated heart disease
• Life expectancy of less than 1 year
• Active peptid ulcer or upper gastrointestinal bleeding within 6 months
• Ongoing systemic infection

• Left ventricular ejection fraction <35 %
• Renal function with eGFR <30 mL/min
• Pregnant or nursing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niels Thue Olsen

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels Thue Olsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte Hospital

Locations

Aarhus University Hospital Skejby

Aarhus, , Denmark

Odense University Hospital

Odense, , Denmark

University Hospital Leuven

Leuven, , Belgium

Gentofte University Hospital

Gentofte Municipality, Copenhagen, Denmark

Aalborg University Hospital

Aalborg, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Zealand University Hospital, Roskilde Sygehus

Roskilde, , Denmark

North-Estonia Medical Center

Tallinn, , Estonia

Trondheim University Hospital

Trondheim, , Norway

Countries

Belgium; Denmark; Estonia; Norway

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H-19051822

Identifier Type: -

Identifier Source: org_study_id