Impact of Rotational Atherectomy on Coronary Microcirculation
NCT05771961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2023-11-13
Summary
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.
Conditions
- Stable Angina
- Coronary Artery Disease
Interventions
- DIAGNOSTIC_TEST
-
coronary pressure/temperature sensor-tipped guidewire
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.
- DIAGNOSTIC_TEST
-
Angiography-derived index of microcirculatory resistance (IMRangio)
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
Sponsors & Collaborators
-
Klaipėda University
collaborator OTHER -
Kreiskrankenhaus Rotenburg an der fluda
collaborator UNKNOWN -
Alkafeel Super Speciality Hospital
collaborator UNKNOWN -
Lithuanian University of Health Sciences
lead OTHER
Principal Investigators
-
Ali Aldujeli · Lithuanian University of Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2024-05-01
- Completion
- 2025-05-01
Countries
- Lithuania
Study Locations
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