CompletedNot Applicable

Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions

Belgium, Denmark, Estonia200 participantsStarted 2020-01-29

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with combined outcome of strategy failure

Timeframe: 1 year

Trial details

NCT IDNCT04253171

SponsorHerlev and Gentofte Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Percutaneous Coronary Intervention trials