Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771961
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-03-05
Brief Title:
Impact of Rotational Atherectomy on Coronary Microcirculation
Sponsor:
Lithuanian University of Health Sciences
Organization:
Lithuanian University of Health Sciences
Study Overview
Official Title:
Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICRO-ROTA
Brief 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 studys 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
The studys 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None