Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

NCT04253171 | Completed DMC FDA Device

• 1 other identifier: H-19051822
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 9

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.

Conditions

Percutaneous Coronary Intervention; Coronary Artery Calcification; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with combined outcome of strategy failure

  Failed stent delivery, residual area stenosis ≥ 20% (OCT-assessed) after PCI, or target vessel failure. Residual area stenosis will be defined as \[1 - in-stent minimal lumen area/reference area\]. The reference area will be calculated by averaging the proximal and distal reference areas, which will be determined by measuring the lumen contours on most healthy-looking frame of the final OCT in the 0-5 mm edge segments. If a reference cannot be measured on the final OCT, it will be measured on a pre-stent OCT or by using quantitative coronary angiography if pre-stent OCT is unavailable. Target vessel failure will be defined as cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization). Failed or no stent delivery is defined as failure to deliver and deploy 1 or more coronary stents to cover the intended length of the intended target lesion.

  1 year

Secondary Outcomes (7)

• Number of patients with composite and components of in-hospital major adverse cardiac events (MACE)

  In-hospital

• Number of patients with composite and components of major adverse cardiac events (MACE)

  1 year

• Number of patients with in-hospital procedure-related adverse events

  In-hospital

• Number of patients with components of the primary outcome

  1 year

• Number of patients with components of target vessel failure

  1 year

Study Arms (2)

Lithoplasty lesion preparation

ACTIVE COMPARATOR

Balloon lithoplasty will be used as lesion preparation.

Device: Lithoplasty

Conventional lesion preparation

ACTIVE COMPARATOR

Conventional and modified balloons will be used as lesion preparation.

Device: Conventional

Interventions

Lithoplasty 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.

Also known as: Shockwave, Lithotripsy

Lithoplasty lesion preparation

Conventional 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.

Conventional lesion preparation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Abbott: collaborator
• Shockwave Medical, Inc.: collaborator

Study Sites (9)

University Hospital Leuven

Leuven, Belgium

Location

Gentofte University Hospital

Gentofte Municipality, Copenhagen, 2900, Denmark

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital, Roskilde Sygehus

Roskilde, 4000, Denmark

Location

North-Estonia Medical Center

Tallinn, Estonia

Location

Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (1)

• Kristensen AT, Christiansen EH, Holm NR, Kelbaek H, Engstrom T, Veien K, Raungaard B, Kleveland O, Bennett J, Laanmets P, Jakobsen L, Havndrup O, Lonborg JT, Ahlehoff O, Iversen A, Vatwani AK, Stottrup NB, Jensen LO, Christensen MK, Haahr-Pedersen SA, Charlot MG, Gabriel EE, Olsen NT. Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions. JACC Cardiovasc Interv. 2025 Nov 18:S1936-8798(25)02480-X. doi: 10.1016/j.jcin.2025.09.028. Online ahead of print.

  PMID: 41400597 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Niels Thue Olsen, MD, PhD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome will be assessed by a blinded clinical events adjudication committee and by a blinded OCT core laboratory analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Investigator-initiated 1:1 randomized, controlled, multinational, superiority trial.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: January 29, 2020
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DK (6); BE (1); NO (1)