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Search / Trial NCT06507449

The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

Launched by MEDICAL UNIVERSITY OF SILESIA · Jul 12, 2024

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Percutaneous Coronary Intervention Microcirculation

ClinConnect Summary

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 will be enrolled. The severity will be assessed by Optical Coherence Tomography (OCT) based on the degree of calcification in the coronary lesion as defined by this protocol. Subjects will be assigned to one of three arms (lithotripsy, super-high pressure balloon or orbital atherectomy) followed by an implantation of drug-eluting stents (DES). The aposition and expansion of DES will be evaluated u...

Gender

ALL

Eligibility criteria

  • 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

About Medical University Of Silesia

The Medical University of Silesia is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. Located in Poland, the university is renowned for its commitment to medical education, interdisciplinary collaboration, and the development of new therapeutic approaches. With a focus on translating scientific discoveries into practical applications, the Medical University of Silesia sponsors a range of clinical trials aimed at improving patient outcomes and enhancing the understanding of various medical conditions. Through its rigorous ethical standards and robust research infrastructure, the university plays a pivotal role in shaping the future of medicine both regionally and globally.

Locations

Katowice, , Poland

Patients applied

0 patients applied

Trial Officials

Paweł Gąsior, MD, PhD

Principal Investigator

Division of Cardiology and Structural Heart Diseases, Medical University of Silesia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported