Impact of Rotational Atherectomy on Coronary Microcirculation

NCT05771961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-11-13

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771961 on ClinicalTrials.gov