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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
Department of Cardiovascular Diseases, University Hospital
Ostrava, Česká Republika, Czechia
RECRUITINGMinimal lumen diamether (MLD)
minimal diamether of treated lesion measured by quantitative coronary angiography
Time frame: 1 year
Late luemn loss (LLL)
difference between post-procedure MLD and 12-month MLD
Time frame: 1 year
Binary in-stent restenosis
diamether stenosis ≥ 50% of reference vessel
Time frame: 1 year
Major adverse cardiac events (MACE)
Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)
Time frame: 1 year
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