Using shockwave therapy to treat calcified coronary arteries
Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study
This study is testing if a new shockwave therapy can help people with hardening arteries get better results from heart stents compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Česká Republika) |
| Trial ID | NCT04428177 on ClinicalTrials.gov |
What this trial studies
This prospective randomized study aims to compare the safety and efficacy of intravascular lithotripsy (IVL) against standard therapies for treating calcified coronary lesions. A total of 40 patients with significant calcification will be enrolled and randomly assigned to receive either IVL or standard treatment methods. The study will assess the effectiveness of IVL in preparing lesions for drug-eluting stent implantation. The goal is to determine if IVL offers a superior approach to managing coronary artery calcification.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant calcified coronary artery lesions suitable for percutaneous coronary intervention.
Not a fit: Patients with severe comorbidities, active malignancies, or those unable to undergo coronary angiography may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with calcified coronary lesions.
How similar studies have performed: While the use of intravascular lithotripsy is a novel approach, similar studies have shown promising results in treating calcified lesions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Informed, written consent by the patient * Ability to comply fully with the study protocol * Negative pregnancy test (and effective contraception) in women with childbearing potential Angiographic inclusion criteria: * Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI * Heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography * Reference vessel diameter (RVD) ≥2.5 mm with lesion length \<32 mm * TIMI flow 3 of the target vessel at baseline * No visible thrombus at target lesion site Exclusion Criteria: * Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support * Active malignancy or other comorbidities with a life expectancy of 12 months * Limited the possibility of control coronaro angiography (e.g., advanced renal failure) * Known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy * Current problems with substance abuse (e.g., alcohol or drugs) * Subject is participating in another investigational drug or device clinical study
Where this trial is running
Ostrava, Česká Republika
- Department of Cardiovascular Diseases, University Hospital — Ostrava, Česká Republika, Czechia (Recruiting)
Study contacts
- Study coordinator: Leos Pleva, MD,PhD.
- Email: leos.pleva@volny.cz
- Phone: +420733414740
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.