Coronary Artery Calcification, Ischemic Heart Disease, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Coronary Artery Disease, Angina, Unstable, Tomography, Optical Coherence
Conditions
Keywords
Percutaneous coronary intervention, Microcirculation
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.
Interventions
DEVICELithotripsy
Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent
DEVICEOrbital atherectomy
Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent
DEVICEHigh-pressure non-compliant balloon
Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent
DEVICEOptical coherence tomography
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.
Sponsors
Polish Cardiac Society
Medical University of Silesia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Flow Reserve (CFR) | Intraprocedural | Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System. |
| Index of Microcirculatory Resistance (IMR) | Intraprocedural | Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal stent expansion | Intraprocedural | Optimal stent expansion (cut-off value defined as \>90%) evaluated by optical coherence tomography. |
| Acceptable stent expansion | Intraprocedural | Acceptable stent expansion (cut-off value defined as \>80%) evaluated by optical coherence tomography. |
| Minimal lumen diameter (MLD) difference | Intraprocedural | Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure. |
| Procedural Success | Up to 3 years | 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). |
| Strategy Success | Intraprocedural | Strategy success - defined as procedural success without crossover to alternative treatment. |
| Stent expansion | Intraprocedural | Stent expansion (%) evaluated by optical coherence tomography. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction (MI) rate at 30-day and 1 year | Up to 3 years | The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year. |
| The proportion of subjects that experience Target Vessel Revascularization (TVR) | Up to 3 years | 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. |
| The proportion of subjects that experience Target Lesion Revascularization (TLR) | Up to 3 years | 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. |
| The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Up to 3 years | 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. |
Countries
Poland
Outcome results
None listed