Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

The study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara, USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation, rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES implantation.

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