Clinical trial NCT06507449: The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Official title: The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Artery Calcification
Ischemic Heart Disease
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
Coronary Artery Disease
Angina, Unstable
Tomography, Optical Coherence
Keywords: Percutaneous coronary intervention
Microcirculation
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Polish Cardiac Society
First posted: 2024-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 subjects assigned to one of three therapeutical methods lithotripsy, super-high pressure balloon, and orbital atherectomy prior to implantation of drug-eluting stents (DES).

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 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 using OCT . Patients will be followed through discharge, 30 days and 12 months.

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

Primary outcomes:
measure: Coronary Flow Reserve (CFR)
timeFrame: Intraprocedural
measure: Index of Microcirculatory Resistance (IMR)
timeFrame: Intraprocedural
Secondary outcomes:
measure: Stent expansion
timeFrame: Intraprocedural
measure: Acceptable stent expansion
timeFrame: Intraprocedural
measure: Optimal stent expansion
timeFrame: Intraprocedural
measure: Minimal lumen diameter (MLD) difference
timeFrame: Intraprocedural
measure: Procedural Success
timeFrame: Up to 3 years
measure: Strategy Success
timeFrame: Intraprocedural
Other outcomes:
measure: The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: Up to 3 years
measure: The proportion of subjects that experience Target Vessel Revascularization (TVR)
timeFrame: Up to 3 years
measure: The proportion of subjects that experience Target Lesion Revascularization (TLR)
timeFrame: Up to 3 years
measure: Myocardial infarction (MI) rate at 30-day and 1 year
timeFrame: Up to 3 years
Locations:
city: Katowice
country: Poland
facility: Upper Silesian Medical Centre
Study officials:
affiliation: Division of Cardiology and Structural Heart Diseases, Medical University of Silesia
name: Paweł Gąsior, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: