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 range18 Years
SexALL
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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…