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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent
Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent
Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent
Optical coherence tomography assessment of coronary arteries.
A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.
Upper Silesian Medical Centre
Katowice, Poland
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.
Time frame: 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.
Time frame: Intraprocedural
Stent expansion
Stent expansion (%) evaluated by optical coherence tomography.
Time frame: Intraprocedural
Acceptable stent expansion
Acceptable stent expansion (cut-off value defined as \>80%) evaluated by optical coherence tomography.
Time frame: Intraprocedural
Optimal stent expansion
Optimal stent expansion (cut-off value defined as \>90%) evaluated by optical coherence tomography.
Time frame: 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.
Time frame: 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).
Time frame: Up to 3 years
Strategy Success
Strategy success - defined as procedural success without crossover to alternative treatment.
Time frame: Intraprocedural
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