Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions (CCS)

University Hospital Ostrava

Status: Enrolling

Conditions: Coronary Artery Calcification

Treatments: Device: Standart therapy; Device: Intravascular lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04428177

06/RVO-FNOs/2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intrvascular Lithotripsy

Experimental group

Description:

Calcified coronary lesions will be treated with intrvascular lithotripsy

Treatment:

Device: Intravascular lithotripsy

Standard therapy

Active Comparator group

Description:

Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy

Treatment:

Device: Standart therapy