Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Not Applicable

Recruiting

• Conditions: Coronary Artery Calcification
• Interventions: Device: Intravascular lithotripsy; Device: Standart therapy

• Registration Number: NCT04428177
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrvascular Lithotripsy	Intravascular lithotripsy	Calcified coronary lesions will be treated with intrvascular lithotripsy
Standard therapy	Standart therapy	Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy

Primary Outcome Measures

Name	Time	Method
Minimal lumen diamether (MLD)	1 year	minimal diamether of treated lesion measured by quantitative coronary angiography
Late luemn loss (LLL)	1 year	difference between post-procedure MLD and 12-month MLD

Secondary Outcome Measures

Name	Time	Method
Binary in-stent restenosis	1 year	diamether stenosis ≥ 50% of reference vessel
Major adverse cardiac events (MACE)	1 year	Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)

Trial Locations

Locations (1)

Department of Cardiovascular Diseases, University Hospital; 🇨🇿 Ostrava, Česká Republika, Czechia