Using shockwave therapy to treat calcified coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry to evaluate outcomes of coronary artery disease patients treated with specific balloon catheters

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.