NCT06507449Enrolling by invitation
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jul 2024
- Start date
- Mar 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Medical University of Silesia
- Diseases
- Coronary artery disease
- NCT number
- NCT06507449
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Mar 2024 to the primary completion date, Jun 2026
- 1 site in 1 country
- 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.
Prior treatment
- 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
Other illness
- 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).
Lab values
- Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR \<30).
- Most recent left ventricular ejection fraction ≤ 20%.
Age
- Male or female, age under 18 years at the time of signing informed consent.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Upper Silesian Medical Centre Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.