The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation (NCT06507449) | Clinical Trial Compass
By InvitationNot Applicable
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Poland30 participantsStarted 2024-03-07
Plain-language summary
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).
Who can participate
Age range
18 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:
* 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 Criteria:
* Inability to understand the study or a history of non-compliance with medical advice.
* Unwilling or unable to sign the Informed Consent Form (ICF).
* History of any cognitive or mental health status that would interfere with trial participation.
* Male or female, age under 18 years at the time of signing informed consent.
* 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.
* 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 diseas…
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.