This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Percutaneous Coronary Intervention using Rotablation
Percutaneous Coronary Intervention using Lithoplasty
University of Giessen
Giessen, Germany
Minimal Stent Area (End of the Procedure)
Time frame: 0 days
Minimal/Mean/Maximal Stent Diameter
Time frame: 0 days
Minimal/Mean/Maximal Lumen area
Time frame: 0 days
Minimal/Mean/Maximal Lumen diameter
Time frame: 0 days
Mean/Maximal Stent area
Time frame: 0 days
Incidence of target lesion failure
Time frame: 0 months; 1 month; 6 months
Incidence of target vessel failure
Time frame: 0 months; 1 month; 6 months
MACE rate
Time frame: 0 months; 1 month; 6 months
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