Status:
ENROLLING_BY_INVITATION
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Polish Cardiac Society
Conditions:
Coronary Artery Calcification
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 subje...
Detailed Description
This prospective, non-randomized, single-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. 30 patients with severe coronary stenosis wil...
Eligibility Criteria
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
- 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 disease stage 4 or greater (eGFR \<30).
- Most recent left ventricular ejection fraction ≤ 20%.
- Subject is an acceptable candidate for coronary artery bypass surgery.
- 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.
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06507449
Start Date
March 7 2024
End Date
December 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
Upper Silesian Medical Centre
Katowice, Poland, 40-081