NCT04253171Completed
Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions
Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions Before Stent Implantation - a Nationwide Randomized Trial (BALI)
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 28 Jan 2020
- Start date
- 29 Jan 2020
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Herlev and Gentofte Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04253171
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 29 Jan 2020 to the primary completion date, 1 Sept 2024
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus University Hospital Skejby Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Gentofte University Hospital Coordinator of this site? Confirm its status | Gentofte Municipality | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Zealand University Hospital, Roskilde Sygehus Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| North-Estonia Medical Center Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Trondheim University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
Related publications
- Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions.JACC Cardiovasc Interv · 2026 · PMID 41400597
This page is information, not medical advice. Discuss any trial with your doctor.