Coronary Artery Calcification
Conditions
Keywords
Coronary Artery Calcification, Intravascular Lithotripsy
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.
Interventions
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
DEVICEStandart therapy
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Angiographic success | up to end of the procedure, an average of 2 hours | success in facilitating stent delivery with \<50% residual stenosis and without serious angiographic complications |
| Clinical success | up to discharge, an average of 3 days | angiographic success with no evidence of in-hospital MACE |
Countries
Czechia
Contacts
Primary ContactLeos Pleva, MD,PhD.
Outcome results
None listed