The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
NCT Number: NCT06507449
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Calcification|Ischemic Heart Disease|Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)|Coronary Artery Disease|Angina, Unstable|Tomography, Optical Coherence
Interventions: DEVICE: Lithotripsy|DEVICE: Orbital atherectomy|DEVICE: High-pressure non-compliant balloon|DEVICE: Optical coherence tomography|DEVICE: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Sponsor: Medical University of Silesia
Collaborators: Polish Cardiac Society
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-07
Completion Date: 2026-12
Locations: Upper Silesian Medical Centre, Katowice, 40-081, Poland

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).

Primary Outcome Measures: Coronary Flow Reserve (CFR), Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System., Intraprocedural|Index of Microcirculatory Resistance (IMR), Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System., Intraprocedural
Secondary Outcome Measures: Stent expansion, Stent expansion (%) evaluated by optical coherence tomography., Intraprocedural|Acceptable stent expansion, Acceptable stent expansion (cut-off value defined as \>80%) evaluated by optical coherence tomography., Intraprocedural|Optimal stent expansion, Optimal stent expansion (cut-off value defined as \>90%) evaluated by optical coherence tomography., Intraprocedural|Minimal lumen diameter (MLD) difference, Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure., Intraprocedural|Procedural Success, Procedural success - defined as successful stent delivery and angiographic in-vessel residual stenosis \<30%, and with the absence of any of the following: stent loss, coronary artery dissection, coronary artery perforation, PCI no reflow phenomenon or MACCE (defined as a composite of cardiovascular death, myocardial infarction at the targeted vessel, targeted coronary vessel revascularization (PCI or CABG), TIA or stroke)., Up to 3 years|Strategy Success, Strategy success - defined as procedural success without crossover to alternative treatment., Intraprocedural
Other Outcome Measures: The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), 30-day and 1 year MACCE defined as a composite of cardiovascular death, myocardial infarction at the targeted vessel, targeted coronary vessel revascularization (PCI or CABG), TIA or stroke., Up to 3 years|The proportion of subjects that experience Target Vessel Revascularization (TVR), 30-day and 1 year Target Vessel Revascularization (TVR) - defined as any repeat revascularization at the target vessel (inclusive of the target lesion) and target vessel collaterals after the completion of the procedure., Up to 3 years|The proportion of subjects that experience Target Lesion Revascularization (TLR), 30-day and 1 year Target Lesion Revascularization (TLR) - defined as repeat intervention PCI or surgery within the index procedure stent or 5mm proximal or distal to the stent., Up to 3 years|Myocardial infarction (MI) rate at 30-day and 1 year, The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year., Up to 3 years