Impact of Rotational Atherectomy on Coronary Microcirculation

NCT05771961 | Unknown DMC

• 1 other identifier: LUHSKC-179
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Coronary Artery Disease

Keywords

Rotational atherectomy; Conventional stenting; CMD; Microcirculation; Index of microcirculatory resistance; IMRangio

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (3)

• Rate of Major adverse cardiovascular events

  1 year

• The incidence of coronary microvascular dysfunction

  1 year

• Seattle Angina Questionnaire score

  1 year

Study Arms (2)

Rotational Atherectomy

ACTIVE COMPARATOR

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.

Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire; Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)

Conventional Stenting

ACTIVE COMPARATOR

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.

Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire; Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)

Interventions

coronary pressure/temperature sensor-tipped guidewire 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.

Conventional Stenting; Rotational Atherectomy

Angiography-derived index of microcirculatory resistance (IMRangio) DIAGNOSTIC_TEST

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

Conventional Stenting; Rotational Atherectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Klaipėda University: collaborator
• Kreiskrankenhaus Rotenburg an der fluda: collaborator
• Alkafeel Super Speciality Hospital: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-50161, Lithuania

RECRUITING

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ali Aldujeli

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Aldujeli

CONTACT

+37064874874; ali.aldujeli@kaunoklinikos.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular disease consultant

Model Details: Participants are randomly assigned to receive either the rotational atherectomy or conventional stenting alone.

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

LI (1)