The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

Korábbi kezelés

• 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

Más betegség

• 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).

Laborértékek

• Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR <30).
• Most recent left ventricular ejection fraction ≤ 20%.

Életkor

• Male or female, age under 18 years at the time of signing informed consent.

Egyéb

• 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.

• 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