Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Calcification

Intervention / Treatment
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* Device: Intravascular lithotripsy
* Device: Standart therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrvascular Lithotripsy<br>Calcified coronary lesions will be treated with intrvascular lithotripsy | Device: Intravascular lithotripsy<br>* Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel<br>|
| Active Comparator: Standard therapy<br>Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy | Device: Standart therapy<br>* conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Calcification, Intravascular Lithotripsy