Percutaneous Coronary InterventionBALINCT04253171
Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions
A study testing Lithoplasty and Conventional in people with Percutaneous Coronary Intervention and Coronary Artery Calcification, run by Herlev and Gentofte Hospital at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Calcification, Coronary Artery Disease
- What is being tested?
- Lithoplasty and Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 29 Jan 2020to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 24Show fewer
- Informed consent
- Angiographic exclusion criteria:
- Unprotected left main stenosis
- Chronic total occlusion
- Severely calcified bifurcated lesion with expected need to use two stent technique
- Coronary artery dissection
- Clinical exclusion criteria
- 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
- Paraclinical exclusion criteria
- Left ventricular ejection fraction <35 %
- Renal function with eGFR <30 mL/min
- Pregnant or nursing
Who cannot join
None listed.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Denmark6 sites
Aalborg University Hospital
Aalborg, 9100
Aarhus University Hospital Skejby
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Gentofte University Hospital
Gentofte Municipality, Copenhagen, 2900
Odense University Hospital
Odense, 5000
Zealand University Hospital, Roskilde Sygehus
Roskilde, 4000
About this study
Official title: Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions Before Stent Implantation - a Nationwide Randomized Trial (BALI)
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.
Read the 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
- Being tested
- Lithoplasty, Conventional
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithoplastyDevice
Also called Shockwave, Lithotripsy
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.
ConventionalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lithoplasty lesion preparation | Active comparator | Balloon lithoplasty will be used as lesion preparation. Receives: Device: Lithoplasty |
| Conventional lesion preparation | Active comparator | Conventional and modified balloons will be used as lesion preparation. Receives: Device: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Number of patients with composite and components of in-hospital major adverse cardiac events (MACE)
Cardiac death, Any myocardial infarction, Stroke
Measured: In-hospital
Number of patients with composite and components of major adverse cardiac events (MACE)
Cardiac death, Any myocardial infarction, Stroke
Measured: 1 year
Number of patients with in-hospital procedure-related adverse events
Periprocedural myocardial infarction, Coronary dissection (beyond intended by lesion preparation), Coronary perforation/rupture
Measured: In-hospital
Number of patients with components of the primary outcome
Failed stent delivery, Residual area stenosis >20% (OCT-assessed) after PCI, Target vessel failure
Measured: 1 year
Number of patients with components of target vessel failure
Cardiac death, Target vessel-related myocardial infarction, Clinically driven target vessel revascularization
Measured: 1 year
OCT outcomes at index procedure
Stent expansion
Measured: During procedure
OCT outcomes at 1 year procedure
In-stent late lumen loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 Jan 2020
- Primary completion1 Sep 2024
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated 1:1 randomized, controlled, multinational, superiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Shockwave Medical, Inc.
- Responsible party
- Principal investigator, Niels Thue Olsen, Herlev and Gentofte Hospital
- Investigators
- Niels Thue Olsen, MD, PhD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253171
- Sponsor's protocol ID
- H-19051822
- Acronym
- BALI
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2020
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. 2026 Feb 9;19(3):331-341. doi: 10.1016/j.jcin.2025.09.028. Epub 2025 Dec 15.
PubMed 41400597
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions Before Stent Implantation - a Nationwide Randomized Trial (BALI)
- ClinicalTrials.gov ID
- NCT04253171
- Acronym / sponsor ID
- BALI / H-19051822
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Calcification, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Abbott, Shockwave Medical, Inc.
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigator-initiated 1:1 randomized, controlled, multinational, superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Lithoplasty lesion preparation | Active comparator | Device: LithoplastyBalloon lithoplasty will be used as lesion preparation. |
| Conventional lesion preparation | Active comparator | Device: ConventionalConventional and modified balloons will be used as lesion preparation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LithoplastyAlso: Shockwave, LithotripsyThe 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. | Device | Lithoplasty lesion preparation |
| ConventionalLesion 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. | Device | Conventional lesion preparation |
Primary outcome
Number of patients with combined outcome of strategy failure
Time frame: 1 year
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.
7 secondary outcomes
Number of patients with composite and components of in-hospital major adverse cardiac events (MACE)
Time frame: In-hospital
Number of patients with composite and components of major adverse cardiac events (MACE)
Time frame: 1 year
Number of patients with in-hospital procedure-related adverse events
Time frame: In-hospital
Number of patients with components of the primary outcome
Time frame: 1 year
Number of patients with components of target vessel failure
Time frame: 1 year
OCT outcomes at index procedure
Time frame: During procedure
OCT outcomes at 1 year procedure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Derived from this study: PubMed 41400597Kristensen 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. 2026 Feb 9;19(3):331-341. doi: 10.1016/j.jcin.2025.09.028. Epub 2025 Dec 15.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Thue Olsen, MD, PhD principal investigator
Herlev and Gentofte Hospital
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithoplasty and Conventional in people with Percutaneous Coronary Intervention and Coronary Artery Calcification, run by Herlev and Gentofte Hospital at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Belgium, Estonia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with combined outcome of strategy failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.