An interventional study of Intravascular lithotripsy and Standart therapy in Coronary Artery Calcification, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
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.
Angiographic inclusion criteria:
Exclusion Criteria:
Calcified coronary lesions will be treated with intrvascular lithotripsy
Device: Intravascular lithotripsy
Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy
Device: Standart therapy
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
Minimal 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
Angiographic success
success in facilitating stent delivery with \<50% residual stenosis and without serious angiographic complications
Time frame: up to end of the procedure, an average of 2 hours
Clinical success
angiographic success with no evidence of in-hospital MACE
Time frame: up to discharge, an average of 3 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Ostrava