Comparing the effects of rotational atherectomy and conventional stenting on coronary microcirculation
Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
This study is testing whether a special heart procedure called rotational atherectomy works better than regular stenting for improving blood flow in the tiny vessels of the heart for people with blocked arteries and stable heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT05771961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effects of rotational atherectomy and conventional stenting on coronary microcirculation in patients with calcified coronary artery lesions and stable coronary artery disease (CAD). Patients will undergo serial invasive and non-invasive microvascular testing before and after the interventions to assess the prevalence of coronary microvascular dysfunction. The study will provide insights into how each procedure impacts blood flow in the smallest vessels of the heart, which is crucial for overall cardiac health.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stable coronary artery calcified lesions requiring percutaneous coronary intervention.
Not a fit: Patients with a history of myocardial infarction, CABG, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with stable CAD, enhancing their heart health and quality of life.
How similar studies have performed: While the approach of comparing these two interventions is not widely tested, previous studies have indicated potential benefits of rotational atherectomy in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kaunas
- Lithuanian University of Health Sciences — Kaunas, Lithuania (Recruiting)
Study contacts
- Principal investigator: Ali Aldujeli — Lithuanian University of Health Sciences
- Study coordinator: Ali Aldujeli
- Email: ali.aldujeli@kaunoklinikos.lt
- Phone: +37064874874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.