LithotripsyOrbital atherectomyHigh-pressure non-compliant balloonOptical coherence tomographyCoroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Lithotripsy: Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent
Orbital atherectomy: Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent
High-pressure non-compliant balloon: Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent
Optical coherence tomography: Optical coherence tomography assessment of coronary arteries.
Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire: A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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
Primary outcome measure(s)
Coronary Flow Reserve (CFR) — Intraprocedural Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Index of Microcirculatory Resistance (IMR) — Intraprocedural Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Trial sites (1)
Facility
City
Region
Status
Upper Silesian Medical Centre
Katowice
Poland
More Medical University of Silesia trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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