Impact of Rotational Atherectomy on Coronary Microcirculation

NCT ID: NCT05771961

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-05-01

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 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.

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.

Conditions

Stable Angina; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotational Atherectomy

Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.

Group Type: ACTIVE_COMPARATOR

coronary pressure/temperature sensor-tipped guidewire

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software

Conventional Stenting

Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.

Group Type: ACTIVE_COMPARATOR

coronary pressure/temperature sensor-tipped guidewire

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Angiography-derived index of microcirculatory resistance (IMRangio)

Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention

Exclusion Criteria

• patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
• Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
• patients had contraindication of adenosine triphosphate (ATP);
• had a history of liver or renal function dysfunction
• Patients with dementia
• Patients being referred to CABG
• unable to provide informed consent;
• had pregnancy or life span < 1 year.
• Presence of sever structural valvular heart disease
• Presence of significant left main disease
• Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
• Inability to perform successful PCI

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klaipėda University

OTHER

Sponsor Role: collaborator

Kreiskrankenhaus Rotenburg an der fluda

UNKNOWN

Sponsor Role: collaborator

Alkafeel Super Speciality Hospital

UNKNOWN

Sponsor Role: collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ali Aldujeli

Cardiovascular disease consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Aldujeli

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Ali Aldujeli

Role: CONTACT

ali.aldujeli@kaunoklinikos.lt

+37064874874

Facility Contacts

Ali Aldujeli

Role: primary

ali.aldujeli@kaunoklinikos.lt

864874874

Other Identifiers

LUHSKC-179

Identifier Type: -

Identifier Source: org_study_id