Comparison of Coronary Lithoplasty and Rotablation (NCT04047368) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Coronary Lithoplasty and Rotablation
Germany70 participantsStarted 2019-06-28
Plain-language summary
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age\>18 yrs
* Stable coronary heart disease or acute coronary syndromes
* Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
* Written informed consent was obtained before the procedure
* Severely calcified coronary lesion with indication for rotablation
Exclusion Criteria:
* Known renal insufficiency (serum creatinine clearance \<30ml/min/1.73m² or receiving dialysis)
* Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
* Cardiogenic shock
* Lesion length \> 32mm
* Bifurcation lesions requiring 2-Stent-Strategies