Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Launched by UNIVERSITY HOSPITAL OSTRAVA · Jun 9, 2020

Keywords

ClinConnect Summary

The Coronary Calcification Study is looking at a new treatment for patients with calcified blockages in their heart arteries. The study compares a technique called intravascular lithotripsy (IVL), which uses sound waves to break up hard calcium deposits, to standard treatments already in use. The goal is to see which method is safer and more effective in helping patients with these kinds of blockages.

To participate in this study, you need to be at least 18 years old, able to give consent, and have a specific type of blockage in your coronary arteries that is more than 50% narrowed due to heavy calcification. You will also need to be in stable health without any serious conditions that might complicate treatment. If you decide to join, you can expect to receive either the new IVL treatment or the standard care while being monitored closely for safety and effectiveness. This study is currently recruiting participants, and it's open to everyone regardless of gender, so it could be an important opportunity for those facing this heart condition.

Gender

ALL

Eligibility 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