Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05771961
Other study ID # LUHSKC-179
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2025

Study information

Verified date November 2023
Source Lithuanian University of Health Sciences
Contact Ali Aldujeli
Phone +37064874874
Email ali.aldujeli@kaunoklinikos.lt
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 1, 2025
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Lithuania Lithuanian University of Health Sciences Kaunas

Sponsors (4)

Lead Sponsor Collaborator
Lithuanian University of Health Sciences Alkafeel Super Speciality Hospital, Klaipeda University, Kreiskrankenhaus Rotenburg an der fluda

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of Major adverse cardiovascular events composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death. 1 year
Secondary 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 year
Secondary Seattle Angina Questionnaire score Evaluates the severity of angina symptoms, physical limitations, and quality of life 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A