The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD. The study's objectives are to: * investigate the impact of rotational atherectomy on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; * investigate the impact of conventional stenting on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; and * compare the impact of both percutaneuos coronary interventions on coronary microvascular dysfunction. Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.
Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr. However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream. Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them. The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
In brief, a 6-F angioplasty guiding catheter without side-holes will be used first used to engage the left main coronary artery. A pressure-temperature sensor guidewire ( PressureWire™ X Guidewire) will be used for physiology measurements including IMR measurements. Pressure measurement from the wire will be first equalized with that of the guiding catheter. Then the pressure sensor will be positioned two-thirds of the way down the LAD artery. Intracoronary nitroglycerin will be administered (100 to 200 μg). Hyperemia will be induced with adenosine intracoronary injections.
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
Lithuanian University of Health Sciences
Kaunas, Lithuania
RECRUITINGThe incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value \< 2.5 U or angio IMR ≥ 25 U
Time frame: 1 day
Rate of Major adverse cardiovascular events
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
Time frame: 1 year
The incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value \< 2.5 U or angio IMR ≥ 25 U
Time frame: 1 year
Seattle Angina Questionnaire score
Evaluates the severity of angina symptoms, physical limitations, and quality of life
Time frame: 1 year
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