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

University Hospital Ostrava1 site in 1 country40 target enrollmentJune 1, 2020

ConditionsCoronary Artery Calcification

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Calcification
Sponsor: University Hospital Ostrava
Enrollment: 40
Locations: 1
Primary Endpoint: Late luemn loss (LLL)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital Ostrava

Responsible Party

Sponsor

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