The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Key facts
- Where
- Katowice, PolandSee the site
Where in Poland
- Upper Silesian Medical CentreKatowice, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Silesia
- Trial code
- NCT06507449
- Record updated
- 24 November 2025
- Original description
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation. We will enroll 30 conveniently sampled subjects assigned to one of three therapeutical methods lithotripsy, super-high pressure balloon, and orbital atherectomy prior to implantation of drug-eluting stents (DES).Read full original descriptionShow less
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation. We will enroll 30 conveniently sampled subjects assigned to one of three therapeutical methods lithotripsy, super-high pressure balloon, and orbital atherectomy prior to implantation of drug-eluting stents (DES).
Inclusion: Subjects with native coronary artery disease (including stable or unstable angina and NSTEMI) suitable for PCI; The lesion must be crossable with the study guide wire; The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm; The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion; Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures; Male or female, age above or equal to 18 years at the time of signing informed consent; Further inclusion criteria may apply.
Exclusion: Subject is an acceptable candidate for coronary artery bypass surgery; Subject has received a heart transplant; Subject has major valve disease and underwent intervention within 30 days prior to randomization; Further exclusion criteria may apply; Inability to understand the study or a history of non-compliance with medical advice; History of any cognitive or mental health status that would interfere with trial participation; Subject has evidence of an active infection on the day of the procedure requiring oral or intravenous antibiotics; Limited long term prognosis due to other conditions; Subjects in cardiogenic shock or with decompensated heart failure (NYHA class IV); Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR <30); Most recent left ventricular ejection fraction ≤ 20%; Male or female, age under 18 years at the time of signing informed consent; Unwilling or unable to sign the Informed Consent Form (ICF); Female subjects who are pregnant or planning to become pregnant within the study period; Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated; The target vessel reference diameter is under 2.0 mm; Target lesion is located in or supplied by an arterial or venous bypass graft; The target vessel has angiographically visible or suspected thrombus; The target lesion is in an in-stent restenosis.