University of Giessen
Giessen, 35392, Germany
NCT Number: NCT04047368
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Giessen, 35392, Germany
Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous Coronary Intervention using Rotablation
Percutaneous Coronary Intervention using Lithoplasty
Time frame: 0 days
Time frame: 0 days
Time frame: 0 days
Time frame: 0 days
Time frame: 0 days
Time frame: 0 months; 1 month; 6 months
Time frame: 0 months; 1 month; 6 months
Time frame: 0 months; 1 month; 6 months
University of Giessen
Other
Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
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